Latest news with #Zervimesine
Malaysian Reserve
10-07-2025
- Health
- Malaysian Reserve
Comprehensive Lewy Body Dementia Market Analysis of Evolving Trends and Anticipated Growth Trajectory During the Forecast Period (2025-2034)
According to DelveInsight's analysis, the Lewy body dementia market is anticipated to increase during the forecast period (2025–2034), owing to the launch of emerging therapies such as Neflamapimod (CervoMed), Zervimesine (Cognition Therapeutics), Nilotinib (KeifeRx), and others, and healthcare spending in the 7MM. LAS VEGAS, July 10, 2025 /PRNewswire/ — Lewy body dementia (LBD) is a progressive neurological condition characterized by the accumulation of abnormal alpha-synuclein protein in the brain. This buildup leads to cognitive impairments, visual hallucinations, Parkinson-like motor symptoms, and fluctuating attention levels. LBD encompasses two main subtypes: Dementia with Lewy bodies (DLB), where cognitive issues arise before or at the same time as motor symptoms, and Parkinson's Disease Dementia (PDD), in which dementia appears more than a year after the onset of motor symptoms. While both share the same underlying pathology involving alpha-synuclein, they differ based on the sequence of symptom development. Diagnosis is primarily clinical, supported by cognitive assessments, neuroimaging, and sleep evaluations, although definitive diagnosis is possible only post-mortem. Treatment is symptom-oriented and includes cholinesterase inhibitors, selective use of Parkinson's medications, and interventions for psychiatric and sleep disturbances, though care must be taken not to worsen cognitive issues. According to DelveInsight, there were around 12 million diagnosed cases of dementia across the 7MM in 2024, with expectations of significant growth through 2034, driven by a rising CAGR. According to DelveInsight's 2024 analysis, approximately 330K diagnosed prevalent cases of DLB were reported in the US, emphasizing the significant disease burden in one of the world's key pharmaceutical markets. This substantial patient population underlines the urgent need for improved diagnostic tools and effective treatment options within the US healthcare landscape. Download the report to understand which factors are driving Lewy body dementia epidemiology trends @ Lewy Body Dementia Treatment Algorithm Currently, LBD has no approved disease-modifying therapies (DMTs), and existing treatments offer only partial symptomatic relief. These are often limited by side effects or may worsen certain symptoms. The complexity of managing overlapping cognitive, motor, and psychiatric issues underscores the urgent need for more effective, targeted, and better-tolerated therapies to improve quality of life for patients. Lewy body dementia presents with a distinctive mix of cognitive, motor, and psychiatric symptoms. Existing treatments tend to address these symptoms individually and often fall short in effectiveness. There is a pressing need for therapies that target multiple symptoms simultaneously or are customized to LBD's underlying neurobiology, offering more comprehensive and lasting care. Patients with LBD are particularly vulnerable to adverse drug reactions, especially from antipsychotics, which can cause severe, even life-threatening side effects. This drug sensitivity severely limits treatment options and adds complexity to clinical management. Safer, more tolerable therapies that alleviate neuropsychiatric symptoms without worsening cognition or motor function are critically needed. Currently, there are no dependable, non-invasive biomarkers to confirm an LBD diagnosis during life. Diagnosis relies mainly on clinical presentation, which often results in misdiagnosis or delayed recognition. A validated biomarker would enhance early and accurate diagnosis, aid in identifying appropriate patient groups, and facilitate clinical trial participation, advancing the development of targeted treatments. Learn more about the Lewy body dementia treatment @ New Treatment for Lewy Body Dementia As the current Lewy body dementia market is marked by a notable lack of approved treatment options, it presents a significant opportunity for the introduction of new therapies. This shortfall highlights the urgent need for innovative drugs that can address the disease's intricate pathology. With limited competition and a strong unmet medical need, companies developing treatments in this area may find a favorable environment. The LBD drug development pipeline remains relatively sparse, with only a handful of pharmaceutical companies actively working on targeted therapies. Although the demand for effective treatments is increasing, innovation is still in its early stages. Promising investigational candidates such as Neflamapimod, Zervimesine, and Nilotinib have shown potential in addressing the multifaceted symptoms of LBD, indicating early progress toward bridging the significant therapeutic gap. Discover which therapies are expected to grab major Lewy body dementia market share @ Lewy Body Dementia Market Report Neflamapimod, an investigational central nervous system (CNS) therapy developed by CervoMed and originally licensed from Vertex Pharmaceuticals, has been granted Fast Track designation (FTD) by the FDA for the treatment of dementia with Lewy bodies (DLB). The drug has exhibited a strong safety profile in over 350 patients and promising efficacy in Phase II studies. CervoMed holds multiple patents for its use and formulation, protecting 2039. Initial proof-of-concept data was released in Q1 2025, with additional results expected in the second half of 2025. A Phase III trial is anticipated in mid-2026, contingent on regulatory feedback and funding. In June 2025, CervoMed announced a strategic hire to bolster the development and commercialization of neflamapimod, along with efforts to reinforce Chemistry, Manufacturing, and Controls (CMC) leadership in preparation for scaling up production. Zervimesine (CT1812) is under investigation for mild-to-moderate DLB. The Phase IIa SHIMMER trial (COG1201) it demonstrated a favorable safety profile and consistent efficacy signals across behavioral, cognitive, functional, and motor areas, with benefits increasing over six months. These results support its continued development. Nilotinib, originally approved by Novartis for a different indication, is being repurposed for Parkinson's disease dementia (PDD). Acting as a c-ABL and DDR-1 inhibitor, it is currently in Phase II trials aiming to enhance protein clearance and mitigate neurodegeneration. Preliminary findings suggest improvements in both cognition and motor skills. KeifeRx is collaborating on Nilotinib's clinical assessment and sees promise in its potential as a disease-modifying therapy for neurodegenerative diseases. KeifeRx is also advancing KFRX05, another candidate for PDD, currently in the IND-enabling stage. Discover more about drugs for Lewy body dementia in development @ Lewy Body Dementia Clinical Trials The anticipated launch of these emerging therapies for Lewy body dementia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Lewy body dementia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for Lewy body dementia is expected to grow at a significant CAGR by 2034. This growth is mainly driven by increased awareness, improved diagnostic capabilities, and an aging global population. The lack of disease-modifying therapies has created a strong demand for novel treatment options. Ongoing clinical trials targeting alpha-synuclein pathology are attracting significant investment. Additionally, regulatory support is accelerating therapeutic development in this underserved neurodegenerative space. DelveInsight's latest published market report, titled as Lewy Body Dementia Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the Lewy body dementia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The Lewy body dementia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Prevalent Cases of Dementia Total Diagnosed Prevalent Cases of LBD Gender-specific Diagnosed Prevalent Cases of LBD Type-specific Diagnosed Prevalent Cases of LBD The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Lewy body dementia market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this Lewy body dementia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the Lewy body dementia market. Also, stay abreast of the mitigating factors to improve your market position in the Lewy body dementia therapeutic space. Related Reports Lewy Body Dementia Pipeline Lewy Body Dementia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key FCS companies, including EIP Pharma Inc., Cognition Therapeutics, Eisai Inc., Sun Pharma Advanced Research Company Limited, Georgetown University, Eli Lilly and Company, CuraSen Therapeutics, Inc., Athira Pharma, Aptinyx Inc., among others. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies including Eisai Co., Ltd., Eli Lilly and Company, Novartis AG, DAIICHI SANKYO COMPANY, LIMITED, AbbVie Inc., Lundbeck, Biogen, Cipla, among others. Alzheimer's Disease Market Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies including AB Science, Alzheon Inc., AriBio Co., Ltd., AgeneBio, Inc., Anavex Life Sciences Corp., Annovis Bio, Inc., Cerecin, BioVie, Cassava Sciences, Novo Nordisk, Eli Lilly, Neurim Pharmaceuticals, Suven Life Sciences, Bristol-Myers Squibb, Karuna Therapeutics, T3D Therapeutics, Inc., Lexeo Therapeutics, Axsome Therapeutics, Inc., Araclon Biotech S.L., Eisai Co., Ltd., TauRx Therapeutics, TrueBinding, Inc., AC Immune SA, Johnson & Johnson, Longeveron Inc., Vaccinex Inc., IGC Pharma LLC, among others. Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, LLC, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur [email protected] +14699457679 Logo: View original content:
Yahoo
20-03-2025
- Business
- Yahoo
Cognition Therapeutics Reports Year End 2024 Financial Results and Provides Business Update
Positive Results with Zervimesine (CT1812) in Phase 2 SHIMMER Dementia with Lewy Bodies (DLB) Phase 2 SHINE Data Show Dramatic Slowing of Cognitive Decline with Zervimesine in a Key Pre-specified Alzheimer's Disease Subgroup 2025 Objective: Advance Zervimesine into Late-stage Trials for DLB and Alzheimer's Disease Management will Review Results at 8:00 a.m. ET on Live Webcast and Conference Call PURCHASE, N.Y., March 20, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates that treat neurodegenerative disorders, (the 'Company' or 'Cognition'), today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. Data readouts in 2024 from the Company's Phase 2 studies in mild-to-moderate Alzheimer's disease and dementia with Lewy bodies (DLB) support the potential of zervimesine (also CT1812) in these patient populations. The Company reprioritized its clinical focus in 2025, concluding enrollment in the Phase 2 dry AMD clinical study in order to devote resources to support the planned registrational programs for Alzheimer's and DLB, and extend the cash runway into the fourth quarter of 2025. Next steps for zervimesine include end-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) to align on plans for Phase 3 clinical protocols for both indications. The company plans to request separate end-of-Phase 2 meetings for Alzheimer's disease and DLB. That process is expected to start in early second quarter of 2025. The FDA typically responds to a request within two weeks. Lisa Ricciardi, Cognition's president and CEO, added, 'Zervimesine delivered positive clinical data during 2024 from two key Phase 2 studies: the SHIMMER study in DLB and the SHINE study in Alzheimer's disease. These results show the value that zervimesine holds as we advance towards Phase 3 clinical trials. Looking ahead, we will meet with the FDA on plans to start Phase 3 studies in Alzheimer's disease and DLB. In parallel, we are actively evaluating options to fund our clinical trials, including potential partnering opportunities with pharmaceutical companies.' 2024 Corporate and Clinical Highlights: Phase 2 results from SHIMMER study in DLB showed strong clinical results – up to 91% slowing compared to placebo – across measures of behavior, function, cognition and movement after 6 months of zervimesine treatment. Results shared in an archived webcast available on the IR webpage or directly by visiting Results were also presented in January 2025 at the International Lewy Body Dementia Conference (ILBDC) by study director, James E Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine. Results from Phase 2 SHINE study in Alzheimer's disease showed a near-total preservation of cognition (via ADAS-Cog11 and MMSE scales) in a population of zervimesine-treated Alzheimer's patients who had lower p-tau217 levels. Results of this analysis were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference by principal investigator, Michael Woodward, MD, associate professor, head of dementia research at Austin Health in Melbourne, Australia. Reported a positive outcome of a masked analysis, referred to as a 'futility analysis,' of the Phase 2 MAGNIFY study of zervimesine in patients with geographic atrophy secondary to dry age-related macular degeneration (dry AMD). Along with published preclinical results, this supports the utility of zervimesine in the treatment of dry AMD. Developed a novel chemical process for the manufacture of zervimesine as part of the Company's Phase 3 readiness plan. Provisional patent applications covering this chemical process have been filed. Published six manuscripts in 2024, including final clinical results from the COG0105 SNAP study, which evaluated oligomer displacement following a single dose of zervimesine; and the COG0202 SEQUEL study, which measured the impact of zervimesine treatment on synaptic activity through quantitative EEG. Conducted 12 presentations in 2024 at six scientific and medical congresses including a podium presentation of results from the Phase 2 COG0201 SHINE of zervimesine in mild-to-moderate Alzheimer's patients at the Clinical Trials on Alzheimer's Disease (CTAD) meeting. Recent EventsIn January 2025, we made the strategic decision to voluntarily conclude the Phase 2 MAGNIFY (COG2201) study to focus resources on our ongoing programs in Alzheimer's and DLB. The early conclusion of MAGNIFY was not the result of any safety concerns. This pipeline prioritization has resulted in cost savings that are expected to extend the company's cash runway. 2024 Financial Results Cash and cash equivalents as of December 31, 2024, were approximately $25.0 million, and total obligated grant funds remaining from the NIA were $50.0 million. Research and development expenses were $41.7 million for the year ended December 31, 2024, compared to $37.2 million for 2023. The increase was primarily related to higher costs associated with activities underway to complete two Phase 2 trials. General and administrative expenses were $12.3 million for the year ended December 31, 2024, compared to $13.5 million for 2023. The decrease was primarily related to lower equity-based compensation and professional fees, partially offset by higher employee compensation and benefits. The Company reported a net loss of $34.0 million, or $(0.86) per basic and diluted share for the year ended December 31, 2024, compared to a net loss of $25.8 million, or $(0.86) per basic and diluted share for 2023. Conference Call Information Management will host a conference call and live webcast to discuss Cognition's financial results today at 8:00 a.m. ET. To participate in the conference call, dial (877) 704-4453 (U.S.) or (201) 389-0920 (international) and provide conference ID number 13751938. Alternatively, you may connect to the live webcast via this link: or by visiting the Investor Relations page of the Cognition website at An archived webcast recording will be available approximately one hour after the conclusion of the live call. About Cognition Therapeutics, Inc. Cognition 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 call, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to statements related to our cash runway; our clinical studies of zervimesine (CT1812) and any analyses of the results therefrom; any expected or implied clinical benefits of zervimesine; the expectation that initial clinical results observed with zervimesine will be replicated in later trials; and our clinical development plans, 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 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 global political changes and global economic conditions, supply chain and labor force; our ability to maintain our listing 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 Therapeutics, Selected Financial Data (in thousands, except share and per share data amounts) For the Year Ended December 31, Consolidated Statements of Operations Data: 2024 2023 Operating Expenses: Research and development $ 41,676 $ 37,196 General and administrative 12,290 13,528 Total operating expenses 53,966 50,724 Loss from operations (53,966 ) (50,724 ) Other income (expense): Grant income 19,549 24,805 Other income, net 666 158 Interest expense (25 ) (27 ) Loss on currency translation from liquidation of subsidiary (195 ) -- Total other income, net 19,995 24,936 Net loss $ (33,971 ) $ (25,788 ) Foreign currency translation adjustment, including reclassifications 195 4 Total comprehensive loss $ (33,776 ) $ (25,784 ) Net loss per share: Basic $ (0.86 ) $ (0.86 ) Diluted $ (0.86 ) $ (0.86 ) Weighted-average common shares outstanding: Basic 39,730,148 30,029,087 Diluted 39,730,148 30,029,087 As of (in thousands) December 31, 2024 December 31, 2023 Consolidated Balance Sheet Data: Cash and cash equivalents $ 25,009 $ 29,922 Total assets 30,234 35,163 Total liabilities 11,484 10,689 Accumulated deficit (175,160 ) (141,189 ) Total stockholders equity 18,750 24,474 Contact Information: Cognition Therapeutics, Inc. info@ Casey McDonald (media) Tiberend Strategic Advisors, Inc. cmcdonald@ Mike Moyer (investors)LifeSci Advisorsmmoyer@ This press release was published by a CLEAR® Verified in to access your portfolio
