Latest news with #AAIC
Times of Oman
2 days ago
- General
- Times of Oman
Kathmandu plane crash: Probe blames Saurya Airlines tragedy on cargo shift, speed errors and oversight lapses
Kathmandu: An investigation into the July 24, 2024, Saurya Airlines crash in Nepal's Kathmandu has revealed multiple technical and manual lapses as the primary causes of the tragic incident that claimed 18 lives, leaving only the pilot alive. The Aircraft Accident Investigation Commission (AAIC) released its final report on Friday, citing several critical lapses in weight and balance management, incorrect takeoff speeds, and regulatory oversight failures as key contributing factors to the crash of the Bombardier CRJ-200 aircraft (registration 9N-AME). One of the major findings was that the aircraft's cargo was likely not secured according to guidelines, which may have shifted during takeoff. The AAIC also pointed out that the takeoff speeds (V-speeds) entered and used by the crew did not match official reference speeds from the aircraft's Quick Reference Handbook (QRH), raising the risk of aerodynamic instability as one of the reasons for the fatal crash. The Commission also attributed the pitch rate during takeoff, which reached an abnormal 8.6° per second, nearly triple the aircraft's safe limit of 3°/s, as the third reason contributing to the accident. In addition, the commission also flagged the lack of regulatory oversight in approving the ferry flight without verifying compliance with safety protocols. The Pokhara-bound aircraft, which had been grounded for 34 days prior to the crash and was scheduled for base maintenance in Pokhara, had undergone short-term storage procedures multiple times and had its return-to-service check completed on the morning of the accident. "While the aircraft had a valid airworthiness certificate, its maintenance records showed time extensions and short-term preparations rather than a long-term, thorough maintenance regime," the report states. The pilot-in-command had over 6,000 hours of total flight time and nearly 5,000 on the CRJ-200, with valid licenses and recent rest. The first officer was less experienced, with around 1,800 total flight hours. There was also a supernumerary (S/N) engineer on board. Despite the apparent fitness of the crew and aircraft, crucial oversights in weight documentation, speed settings, and preflight planning may have compromised the safety of the flight. The ill-fated aircraft, bound for Pokhara, was carrying 19 individuals and 600 kg of baggage. The total takeoff weight was 18,132 kg, and the centre of gravity (CG) was at 20 per cent of the MAC (Mean Aerodynamic Chord) with a stabiliser trim set to 6. The report also has highlighted that the cargo loading protocols are insufficient. Investigators found that cargo and baggage may not have been properly secured with straps or nets, as required by the airline's own Ground Handling Manual. Shifting loads during takeoff can significantly impact balance and control, especially in a rear-heavy configuration. "The incorrect stabiliser setting or unbalanced CG may have contributed to the rapid pitch-up, causing a stall or loss of control," the report states. The AAIC also identified non-compliance with standard loading procedures as a key safety violation, emphasising that such oversights are unacceptable even in ferry or non-revenue flights. Along with the Civil Aviation Authority of Nepal (CAAN), the oversight body of the aviation regulatory body of the Himalayan nation lacks oversight. Saurya Airlines obtained ferry flight approval for this non-revenue flight from Kathmandu to Pokhara. However, investigators found that the flight permission process was inadequately followed. "The required documentation, including full compliance with CAAN's 2015 Flight Permission Manual, was incomplete or missing. This regulatory lapse enabled a flight to proceed without proper checks on critical safety elements like load distribution and updated speed charts," it states. In its report, the AAIC has recommended that CAAN (Civil Aviation Authority) urgently review and revise procedures for ferry and non-scheduled flights to ensure such incidents do not recur. The Flight Data Recorder (FDR) and Cockpit Voice Recorder (CVR) were successfully recovered and analysed in Singapore, with oversight from Nepal's AAIC and international observers from Canada, the USA, and the FAA. "The data showed that the aircraft's engines functioned normally during the event. However, a dangerously high pitch rate, peaking at 8.6° per second, was recorded during rotation, far exceeding safe limits," the AAIC report states. "The CVR recorded multiple stick shaker activations, indicating stall warnings. The aircraft also exhibited erratic roll movements: right, then left, and again right. Despite the pilot-in-command's attempts to correct the aircraft's attitude using control wheel inputs, the instability continued until impact," it adds further. Three interim safety recommendations have been issued further by the AAIC, where it has mentioned, "all airline operators in Nepal must immediately review their speed cards and Reduced Takeoff Weight (RTOW) charts to ensure accuracy and conformity with the aircraft manuals." Also, the strict compliance with cargo and baggage handling procedures is mandated for all the operating airlines, where "every piece of baggage or cargo must be weighed, correctly distributed, and securely fastened using nets or straps." Along with the regulatory body, the Civil Aviation Authority of Nepal must revise and improve its procedures for granting flight permissions, especially for non-scheduled and ferry flights. On July 24, 2024, the Saurya Airlines Bombardier CRJ 200 aircraft (registration 9N-AME) crashed shortly after takeoff at Tribhuvan International Airport (TIA) in Kathmandu. The aircraft was on a ferry flight to Pokhara for scheduled maintenance, carrying 19 airline personnel, including pilots and engineers. Within seconds of liftoff from runway 02 at around 11:11 AM local time, the plane veered sharply right and crashed near runway 20, erupting in flames. Rescue teams, including firefighters, police, and army personnel, responded swiftly, extinguishing the fire and recovering the bodies, later sent for autopsy. The crash prompted a temporary shutdown of TIA, disrupting domestic and international flights. The government-formed investigation committee submitted its report following the Saurya Airlines Bombardier CRJ-200 crash that occurred on July 24, 2024. The five-member commission was established immediately after the accident during an emergency Cabinet meeting to determine the causes of the crash. It was led by Ratish Chandra Lal Suman, the former Director General of the Civil Aviation Authority of Nepal (CAAN). The other members were Captain Dipu Jwarchan, Professors Kuldip Bhattarai and Sanjay Adhikari from Pulchowk Engineering Campus, and Mukesh Dangol, an Air Traffic Control Officer at CAAN. The committee completed its investigation and submitted the report, providing detailed findings on the circumstances and factors that led to the tragic accident, which claimed 18 lives.
Yahoo
4 days ago
- Health
- Yahoo
Cognition Therapeutics' Positive Clinical Data from Zervimesine (CT1812) Phase 2 Study in Dementia with Lewy Bodies (DLB) will be Presented in a Podium Presentation at AAIC
- Zervimesine-treated participants tested 86% better on behavioral outcomes (NPI 12), 52% on activities of daily living, 91% on cognitive fluctuations, and 62% on motor symptoms as compared to placebo - - Additional presentations highlight positive clinical and biomarker effects of zervimesine in the low p-tau217 population in Phase 2 Alzheimer's disease study - PURCHASE, N.Y., July 16, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that James E. Galvin, MD, MPH will present results from the Phase 2 'SHIMMER' study of zervimesine (CT1812) in dementia with Lewy bodies (DLB) during an oral presentation at the Alzheimer's Association International Conference (AAIC). Dr. Galvin is director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and was the COG1201 SHIMMER study (NCT05225415) director. The presentation will take place on July 29, 2025 in the 8:00 a.m. ET Featured Research Session. 'The results of the Phase 2 SHIMMER study give hope to the millions of people living with DLB and their healthcare teams, who struggle to treat this complex disease,' stated Dr. Galvin. 'My colleagues and I believe that there is great potential in a once-daily oral medication that slows disease progress while simultaneously reducing the severity and frequency of some of the most troublesome symptoms of DLB.' DLB is the second most common cause of dementia, affecting approximately 1.4 million Americans. People living with DLB experience a variety of symptoms, which typically include neuropsychiatric features such as hallucinations, delusions and agitation; cognitive impairment; Parkinsonian movement disorders; REM sleep behavior disorder; and fluctuations in attention and awareness. Currently no disease-modifying therapeutics are approved for DLB. Anthony Caggiano, MD, PhD, Cognition's CMO and head of R&D added, 'Zervimesine's broad neuroprotective mechanism is illustrated by the favorable results observed in the Phase 2 SHIMMER study in DLB. In the SHIMMER study, zervimesine treatment slowed the progression of DLB's diverse symptomology, with a meaningful impact on neuropsychiatric, motor, functional, and cognitive measures. Results from the Phase 2 'SHINE' study in people with Alzheimer's disease add further evidence to zervimesine's neuroprotective properties. We look forward to presenting results from both studies at AAIC.' The SHINE study was a signal-finding trial that showed zervimesine treatment preserved cognitive and functional abilities better than placebo in people with mild-to-moderate Alzheimer's disease. This impact was more robust in participants with lower levels of p-Tau217, who experienced a 95% slowing of cognitive decline at six months as measured by ADAS-Cog 11 compared to placebo. Cognition will present clinical efficacy results and new proteomic findings from this Alzheimer's study at AAIC. Dr. Galvin's slide presentation as well as Cognition's three posters will be available on the Cognition Therapeutics website in accordance with the conference's embargo policy. Cognition at AAIC: Featured Research Session: • Baseline Characteristics and Results of the Phase 2 COG1201 SHIMMER Study of Zervimesine (CT1812): 8:00-8:45 a.m. on July 29 Posters: • Zervimesine (CT1812) Treatment Benefits Patients with Lower Baseline Plasma p-tau217 Across the Mild-to-Moderate AD Spectrum: (#106858) July 27 • Exploratory CSF proteomic analysis of a pre-specified pTau217 subgroup from the SHINE clinical trial identifies biomarkers correlated with cognitive improvement in Alzheimer's disease patients treated with zervimesine: (#102120) July 27 • An exploratory proteomics plasma biomarker analysis of the SHIMMER Phase 2 clinical trial to assess the pharmacodynamic effect of the sigma-2 receptor modulator zervimesine in dementia with Lewy bodies patients: (#106855) July 27 About the SHIMMER Study in Dementia with Lewy BodiesThe SHIMMER study (COG1201; NCT05225415) is an exploratory double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB, who were randomized to either daily oral doses of zervimesine (100 mg or 300 mg) or placebo for six months. A total of 88 participants were randomized to the two treatment arms and 42 to the placebo arm. Assessments were conducted throughout the study using a number of tools, including the Neuropsychiatric Inventory (NPI) to measure changes in hallucinations, anxiety and delusions; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research Battery (CDR), which track cognitive performance; and the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism. The SHIMMER study is supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million (R01AG071643) and was conducted in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA). About the SHINE Study in Mild-to-Moderate Alzheimer's Disease The SHINE study (NCT03507790) is a double-blind, placebo-controlled Phase 2 signal-finding trial that enrolled 153 adults with mild-to-moderate Alzheimer's disease who were evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which was taken orally daily for six months. The primary endpoint was safety and tolerability. The key secondary endpoint of cognition was ADAS-Cog 11. Exploratory endpoints included change in MMSE, ADAS-Cog 13, ADCS-ADL and -CGIC as well as pre-specified subgroup analyses included a comparison of cognitive and functional changes in participants with plasma p-tau217 levels above and below the median. The SHINE study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million. About Zervimesine (CT1812)Zervimesine (CT1812) is an investigational, oral, once-daily pill in development for the treatment of CNS diseases such as Alzheimer's disease and dementia with Lewy bodies (DLB). While these diseases have different symptoms, both are associated with the buildup of certain proteins in the brain – Aβ and ɑ-synuclein. As these proteins bind to neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person's ability to learn, recall memories, move efficiently, or communicate. These diseases progress relentlessly and ultimately result in death. If zervimesine can interrupt the toxic effects of these proteins, it may be able to slow progression of disease and improve the lives of those suffering from Alzheimer's and DLB. Zervimesine has been generally well tolerated in clinical studies to date. Zervimesine has been granted FDA Fast Track designation in Alzheimer's disease. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. About Cognition Therapeutics, Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We currently are investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer's disease, including the ongoing START study (NCT05531656) in early Alzheimer's disease. We believe zervimesine and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases that are functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our future clinical development plans, and statements regarding our clinical trials of zervimesine and any analyses of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as 'may,' 'might,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'seek,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'forecast,' 'potential' or 'continue' or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the 'Risk Factors' section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information:Cognition Therapeutics, Casey McDonald (media)Tiberend Strategic Advisors, Mike Moyer (investors)LifeSci Advisorsmmoyer@ This press release was published by a CLEAR® Verified individual.
National Post
08-07-2025
- Health
- National Post
Alpha Cognition to Present ZUNVEYL® (Benzgalantamine) Study Data at Alzheimer's Association International Conference
Article content VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' or the 'Company'), a commercial-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced it will present new clinical data on ZUNVEYL at the Alzheimer's Association International Conference (AAIC), taking place July 27–31, 2025, in Toronto, Canada. The Company will share the following poster presentations: Article content Bioequivalence of ZUNVEYL Article content Article content , a Galantamine Prodrug to Galantamine Hydrobromide Extended-Release Demonstrated Under Article content Steady State Article content Conditions (Poster #107147) – July 27 Article content Bioequivalence of ZUNVEYL Article content , a Galantamine Prodrug to Galantamine Hydrobromide Immediate-Release Demonstrated Under Article content Fed and Fasting Conditions Article content (Poster#107030) – July 28 Article content , a Galantamine Prodrug, Over a Dosage Range of Five to Fifteen Milligrams Demonstrated Under Fasting Conditions (Poster #107255) -July 30 Article content 'We are excited to present data demonstrating ZUNVEYL's bioequivalence and dose proportionality,' said Dr. Denis Kay, Chief Scientific Officer of Alpha Cognition. 'Given the high unmet need and challenges with current treatments, ZUNVEYL has the potential to offer physicians a well-tolerated therapy with compelling clinical benefits.' Article content AAIC is the world's largest forum for dementia research, convening global leaders in basic and clinical science to advance prevention, diagnosis, and treatment of Alzheimer's disease. Article content About Alpha Cognition Inc. Article content Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options. Article content ALPHA-1062 formulated as a delayed release oral tablet (ZUNVEYL), is an FDA approved new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as a sublingual formulation for cognitive Impairment with mTBI. Article content ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. Article content IMPORTANT SAFETY INFORMATION Article content CONTRAINDICATIONS Article content ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. Article content WARNINGS AND PRECAUTIONS Article content Serious Skin Reactions Article content : Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Article content Anesthesia Article content Cardiovascular Conditions: Article content Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Article content Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Article content Gastrointestinal Conditions Article content : Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Article content Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL. Article content Genitourinary Conditions: Article content Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Article content Neurological Conditions: Article content Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. Article content Pulmonary Conditions: Article content Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions. Article content ADVERSE REACTIONS Article content The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Article content DRUG INTERACTIONS Article content Use with Anticholinergics: Article content Galantamine has the potential to interfere with the activity of anticholinergic medications. Article content Use with Cholinomimetics and Other Cholinesterase Inhibitors: Article content A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. Article content USE IN SPECIFIC POPULATIONS Article content Pregnancy: Article content Based on animal data may cause fetal harm. Article content Hepatic Impairment: Article content In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended. Article content Renal Impairment: Article content In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended. Article content These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Article content Forward-looking Statements Article content This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the, the long-term benefits of ZUNVEYL, the Company's timing and planned activities and business strategy to launch ZUNVEYL, the potential timing for the availability of ZUNVEYL, the potential future developments of ZUNVEYL, the market size and demand for ZUNVEYL and the Company's potential growth opportunities, capital requirements. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks related to our focus on the long-term care market, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's Form S-1/A registration statement as filed with the SEC on January 10, 2025 and available at These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law. Article content Article content Article content
Yahoo
30-06-2025
- Business
- Yahoo
INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease
In the Phase 2 MINDFuL trial of XPro™ in patients with early Alzheimer's Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT) population (n=200) did not meet the primary cognitive endpoint (EMACC), however in a predefined population of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100), a benefit of XPro™ treatment over placebo was observed in cognitive, behavioral and biological endpoints. Treatment with XPro™ was well-tolerated and safe, even in the high risk ApoE4+/+ patient group, and ARIA-E or ARIA-H was not observed in any patients. The most common adverse events (AE) were injection site reactions. Additional analyses will be presented at Alzheimer's Association International Conference (AAIC) in Toronto, Canada (July 27-31, 2025) and the Company will submit for Breakthrough Therapy designation with the FDA. Conference call today at 8AM ET, details below. Boca Raton, June 30, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), today announced results from its Phase 2 MINDFuL trial (NCT05318976) evaluating XPro™, a selective soluble TNF inhibitor, in early AD with biomarkers of inflammation. Despite showing no effects in the modified intent-to-treat population (mITT, n=200), predefined analyses demonstrated a cognitive benefit for XPro™ over placebo on the primary endpoint EMACC, a behavioral benefit on the Neuropsychiatric Inventory, and a biological benefit on pTau217 in early Alzheimer's patients with two or more biomarkers of inflammation at baseline (n=100), marking a key milestone in the development of XPro™ for Early AD. The MINDFuL trial, a double-blind, placebo-controlled study, enrolled 208 participants with early-stage AD to assess XPro™'s potential in slowing cognitive decline by tackling neuroinflammation. Patients with at least one of four inflammatory biomarkers (elevated CRP, ESR, HbA1c, or at least one ApoE4 allele) were randomized 2:1 (XPro™:placebo) and treated over 24 weeks. The primary endpoint was change in cognition over 6 months on the Early Mild Alzheimer's Cognitive Composite (EMACC), a cognitive assessment designed specifically to measure change in early AD patients. While the primary endpoint was not met in the mITT group, key changes in clinical measures of cognition, behavior, and an AD-related biomarker demonstrated a benefit in a subpopulation of patients treated with XPro™ over patients treated with placebo. These results identify a clear population of AD patients for which XPro™ might have therapeutic benefit. Key Findings in the Amyloid positive Early AD participants with two or more biomarkers of inflammation (N=100): Cognition: A clinical benefit of XPro™ over placebo was observed on the primary endpoint EMACC (effect size: 0.27) and on the secondary endpoint Neuropsychiatric Inventory (effect size: -0.24). Alzheimer's Disease Biomarkers: A biological benefit of XPro™ over placebo was observed in blood levels of pTau217 (effect size: -0.20), the gold standard measure of AD pathology in blood. Safety and tolerability: XPro™ treatment was safe and well tolerated, without any occurrences of ARIA-E or ARIA-H. Injection site reactions (ISR) were common (80% of XPro™ group compared to placebo group (<20%). ISRs were short-term redness and/or pain at the injection site in two thirds of cases. Of the 14 patients in the XPro™ arm that discontinued the trial, ISR was the cause in 10 patients. There were no deaths, drug-related hospitalizations or organ system toxicity in the trial. Novel mechanism of action: This study demonstrates that it is possible to safely target neuroinflammation in patients where neuroinflammation is a driver of AD pathology. With the increased interest in inflammation as a disease-modifier in AD and neurodegeneration, these results provide the basis for further development of XPro™ in neurodegeneration. 'These results highlight the potential of XPro™,' stated RJ Tesi, MD, CEO of INmune Bio. 'Our findings indicate that XPro™ may offer benefits to Alzheimer's patients across all age groups, regardless of comorbidities, additional medications, or ApoE4 status. This evidence lays the foundation for advancing XPro™ as a promising treatment option for Alzheimer's disease.' CJ Barnum, PhD, VP of CNS Drug Development, added, 'By targeting neuroinflammation, a key driver of Alzheimer's disease progression, XPro™ offers a novel mechanism to potentially slow disease progression and cognitive symptoms for persons living with Alzheimer's disease and inflammation. The continued development of this therapeutic, whether as a standalone treatment or in combination with other therapies, holds promise in addressing this critical and growing unmet medical need.' Additional analyses are underway and will be presented at AAIC in Toronto, Canada (July 27-31, 2025). Expert Commentary on Use of Effect Size in Clinical Trials 'In early-phase Alzheimer's disease trials, absolute effect sizes of 0.2 or greater are considered preliminary evidence of potential therapeutic efficacy and are informative for signal detection in early phase studies when sample sizes are small and the unknowns of a novel mechanism are significant,' said Dr. Judith Jaeger, a leading expert in cognitive assessment and consultant to INmune Bio on this trial. 'When a therapy consistently meets the 0.2 benchmark across multiple parameters (clinical and biological), confidence in the validity of the observed effects increases, indicating a therapy is worth advancing.' Next Steps INmune Bio will present additional analyses from the MINDFuL trial at AAIC® in Toronto, Canada (July 27-31, 2025). Based on the totality of the data, the company intends to: File for Breakthrough Therapy Designation with the FDA. Schedule an End-of-Phase 2 meeting with the FDA in Q4 2025 to define the path for a pivotal trial to support XPro™ approval in early AD. Engage regulatory authorities in the UK, EU, and other regions in parallel. MINDFuL Results Call Information: To participate in this event, dial approximately at least 10 minutes before the beginning of the call or use the webcast link below. Please ask for the INmune Bio MINDFuL Conference Call when reaching the operator. Date: June 30, 2025Time: 8:00 AM Eastern TimeParticipant Dial-in: +1-800-267-6316 Participant Dial-in (international): +1-203-518-9783Conference ID: INMUNE NOTE: THIS CONFERENCE ID WILL BE REQUIRED FOR ENTRY To join by webcast link please click here or copy and past the link below into your browser: A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through July 30, 2025 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin no. 11159260. Acknowledgements INmune Bio wishes to extend their gratitude to the participants, caregivers, trial site staff, vendors, and any others who supported the efforts of this proof-of-concept phase 2 clinical trial. About MINDFuL (NCT05318976) The MINDFuL trial is an international, blinded, randomized Phase 2 trial in patients with Early AD with biomarkers of elevated neuroinflammation. Early AD includes patients with MCI (mild cognitive impairment) and mild AD. Patients must have at least one of four biomarkers of inflammation – elevated CRP, HgbA1c, ESR or ApoE4 allele. Patients receive either XPro™ or placebo (2:1 ratio) for 6 months. The cognitive endpoints are EMACC and CDR. XPro™ is given as a once-a-week subcutaneous injection. For more information on the MINDFuL clinical trial please visit or About Judith Jaeger, PhD Judith Jaeger, PhD, is the principal developer of the EMACC. Judith Jaeger PhD is founder and President of CognitionMetrics, a prominent neurocognition consulting firm. Dr. Jaeger is an internationally recognized expert in designing cognitive function testing programs to use in clinical trials with more than two decades' experience. About EMACC The EMACC is a validated cognitive composite derived from six standardized neuropsychological tests, empirically developed to provide optimal for sensitivity to decline in early AD. Unlike traditional clinical rating scales, EMACC minimizes variance from informant demographics, providing an objective measure of cognitive performance with no floor or ceiling effects. About XPro™ XPro™ is an advanced tumor necrosis factor (TNF) inhibitor that targets soluble TNF (sTNF) while preserving trans-membrane TNF (tmTNF) and TNF receptors. By reducing neuroinflammation, XPro™ may offer significant benefits for patients with neurologic disorders, potentially enhancing cognitive function and supporting neuronal communication. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat Mild Alzheimer's disease, Mild Cognitive Impairment and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune® developed to prime a patient's NK cells to eliminate minimal residual disease in patients with cancer and is currently in trials in metastatic castration-resistance prostate cancer. The third program, CORDStrom™, is a proprietary allogeneic, pooled, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. INmune Bio's product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and cancer. Forward Looking Statements Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including the results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations for the treatment of XPro™, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDstrom™, XPro1595 (XPro™, pegipanermin), and INKmune®™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release. Company Contact: David Moss Chief Financial Officer (561) 710-0512info@ Daniel Carlson Head of Investor Relations (415) 509-4590dcarlson@ in to access your portfolio
Yahoo
24-06-2025
- Business
- Yahoo
Spinogenix Announces Full Enrollment in its Phase 2 Trial Evaluating SPG302 as a First-in-Class Synaptic Regenerative Therapy for Alzheimer's Disease
First Cohort Results to be Presented at AAIC in Toronto, July 2025 FDA Clears IND in Alzheimer's Disease, Enabling Future Expansion to U.S. LOS ANGELES, June 24, 2025 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced full enrollment of its Phase 2 clinical trial in Australia evaluating SPG302 for the treatment of people with Alzheimer's disease (AD). SPG302 is a once-daily pill with the potential to regenerate synapses and reverse cognitive decline in people with mild to moderate AD. Spinogenix is completing a randomized, double-blind, placebo-controlled Phase 2 study of SPG302 (NCT06427668) to assess the safety, tolerability, and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. Two dose cohorts are being evaluated in a total of 24 participants. The first cohort has completed 24 weeks of treatment (inclusive of a double-blind phase and an open label extension period). Results from this cohort will be presented at the Alzheimer's Association International Conference (AAIC) in Toronto on July 27-31, 2025. In parallel, the U.S. Food and Drug Administration (FDA) cleared Spinogenix's Investigational New Drug (IND) application for SPG302 for the treatment of people with AD. "Full enrollment in our first AD clinical trial marks a significant step in our mission to bring SPG302 to patients and their loved ones suffering from this debilitating condition, and we are eager to share the encouraging results from our first patient cohort at AAIC," said Dr. Stella Sarraf, Spinogenix CEO and Founder. "The FDA's vote of confidence in SPG302 as a candidate treatment for AD – and the opportunity to evaluate this innovative therapy in the U.S. – represents the next step forward for Spinogenix, as we work to provide hope to the more than 55 million people worldwide battling AD, and pursue our mission in leaving no patients behind on the journey to find new treatment options." AD is the most common cause of dementia, accounting for 60-70% of cases worldwide. Loss of synapses occurs very early in AD and is a major driver of cognitive and memory decline. SPG302 offers the first synaptic regenerative approach to treating AD with the potential to improve cognition and quality of life. As such, SPG302 represents a potential new class of regenerative medicine therapeutics that can be used in combination with standard of care cholinesterase inhibitors, as well as recently approved antibody therapies targeting amyloid beta. "We have long understood that synapse regeneration could be the key to improving cognition and quality of life in people with Alzheimer's," said Dr. Bruce Brew, MD, DSc, FRACP, FAAN, neurologist and Principal Investigator at St. Vincent's Hospital in Sydney, Australia. "Current therapies may slow disease progression, but they come with significant side effects and offer little improvement in cognitive function. SPG302 is the first therapy that may soon realize the promise of synapse regeneration, opening an entirely new avenue for treatment. The early trial results are promising, and FDA clearance of this IND opens the door for expansion of trials in the U.S., marking an important step forward in the journey to transform how we manage AD." "I am thrilled by the latest milestone achieved by the Spinogenix team in advancing SPG302 in Alzheimer's disease, and look forward to U.S. patients having the opportunity to participate in important and groundbreaking clinical trials," added Jerre Stead, Chairman of Banner Alzheimer's Institute, Chairman of Stead Impact Ventures, and member of the Spinogenix Board of Directors. About SPG302SPG302 is a once-a-day pill being developed as a regenerative treatment for neurodegenerative and neuropsychiatric diseases with the unique ability to restore synapses, the key connections between neurons that allow people to think, plan, remember, and control movement. The synaptic regenerative activity of SPG302 represents a first-in-class approach to treating these diseases and has the potential to reverse declines in cognitive, respiratory, and motor function. SPG302 is being evaluated as an investigational therapeutic in three disease indications: Alzheimer's disease (NCT06427668), ALS (NCT05882695) and Schizophrenia (NCT06442462). About SpinogenixCurrent treatments for neurodegenerative, neuropsychiatric and neurodevelopmental conditions primarily focus on slowing disease progression or minimizing symptoms, leaving many without hope for improvement. Spinogenix is aiming to transform the treatment of these conditions through its pioneering first-in-class and paradigm-shifting synaptic regenerative and synaptic corrective therapeutics designed to restore depleted synapses and reverse synaptic degeneration and dysfunction – offering patients and their families a new reality of hope. Spinogenix is developing two novel therapeutics: SPG302, which triggers neurons to produce new glutamatergic synapses and restore cognitive, motor, and other functions in ALS, Alzheimer's disease, schizophrenia and other diseases; and SPG601, which works at the synaptic level to correct specific dysfunctions in Fragile X Syndrome (FXS) that underlie many core symptoms. The company has received FDA and EMA Orphan Drug designations for ALS as well as FDA Orphan Drug and Fast Track designations for FXS. More information on Spinogenix can be found at or follow us on LinkedIn. Media ContactArielle Bernstein PinsofFINN Investor RelationsDan AlbostaSpinogenix, View original content: SOURCE Spinogenix
