Latest news with #ErezAminov
Miami Herald
25-06-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Announces New Data Underscoring Potential of SKNY-1 - A Drug Candidate Pending Acquisition - To Disrupt Weight Loss and Smoking Cessation Markets Without CNS Side Effects
MIAMI, FL / ACCESS Newswire / June 25, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new in vitro preclinical data generated by Eurofins supporting the therapeutic potential of SKNY-1, a next-generation oral drug candidate being developed by SKNY Pharmaceuticals, Inc. ("SKNY"). MIRA has signed a definitive agreement to acquire SKNY, and the proposed transaction remains subject to regulatory review and shareholder approval. SKNY-1 is being developed to help individuals lose weight and quit smoking by targeting key biological pathways involved in appetite, addiction, and reward-without triggering the central nervous system (CNS) side effects that have historically limited cannabinoid-based therapies. "We believe SKNY-1 could be a first-in-class oral therapy for two of the largest and most underserved markets: obesity and nicotine addiction," said Erez Aminov, CEO of MIRA. "What makes this drug candidate so exciting is its precision-it's engineered to avoid the psychiatric side effects that doomed earlier drugs in this class, while offering a safe, convenient, once-daily oral option." Designed for Selectivity and SafetyPrevious CB1-targeting drugs, such as rimonabant (Acomplia®, Sanofi), showed weight loss and metabolic results but were ultimately withdrawn from the market due to serious psychiatric side effects, including depression and suicidal ideation.¹ These effects stemmed from non-selective inhibition of CB1 signaling in the brain. In contrast, in vitro studies conducted by Eurofins demonstrated that SKNY-1 acts as a biased CB1 modulator-selectively blocking the β-arrestin signaling pathway, which is associated with cravings and compulsive behavior, while preserving G-protein signaling, which is important for emotional and cognitive stability. This selective mechanism is designed to reduce cravings and body weight without disrupting mood. A Dual Receptor Strategy-Engaging CB2 for Metabolic SupportIn addition to CB1 modulation, SKNY-1 also interacts with the CB2 receptor, which plays a critical role in metabolic regulation and inflammation. Eurofins' in vitro data show that SKNY-1 behaves as a partial CB2 agonist, potentially enhancing fat metabolism, reducing peripheral inflammation and improving insulin sensitivity. This dose-dependent flexibility distinguishes SKNY-1 from earlier CB1-only drugs and may enable a broader therapeutic impact on obesity-related pathways. "SKNY-1 combines modern pharmacology with real-world practicality," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "By precisely modulating CB1 and CB2 and supporting dopamine stability, it targets obesity and addiction through multiple, complementary mechanisms while potentially avoiding cannabinoid-related psychiatric side-effects." Dopamine Stability Without Stimulant RiskSKNY-1 also mildly inhibits the MAO-B enzyme, helping regulate dopamine, a neurotransmitter involved in motivation, focus, and reward. Unlike older monoamine inhibitors, SKNY-1 does not inhibit MAO-A, reducing the risk of serotonin-related side effects. Importantly, the compound demonstrated no or minimal antagonist binding to dopamine receptors (D1, D2, D3), further supporting its favorable CNS safety profile. A Differentiated Alternative to InjectablesWhile injectable GLP-1 drugs have gained market attention, they are often associated with gastrointestinal side effects and muscle loss. SKNY-1 is being developed as an oral therapy with a profile and expected mechanism that may help preserve muscle mass and improve patient adherence by avoiding injections. Market Outlook and Strategic FitObesity and smoking remain two of the world's leading causes of preventable death. The global obesity drug market is projected to surpass $150 billion in value by 2030, and the U.S. smoking cessation market is forecast to grow from $28 billion in 2024 to over $50 billion by decade's end. Pending the completion of the proposed acquisition, MIRA believes SKNY-1 could become a cornerstone asset within its pipeline, offering a next-generation solution to two major health challenges. The Company is currently finalizing animal data related to weight loss and nicotine addiction, which will further support its development strategy and future regulatory filings. MIRA has submitted the required regulatory filings to the U.S. Securities and Exchange Commission (SEC) in connection with the proposed acquisition of SKNY. A shareholder vote will follow in accordance with SEC regulations. For more information, please visit: About MIRA Pharmaceuticals, Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as anxiety, cognitive decline, neuropathic pain, obesity, and addiction. Cautionary Note Regarding Forward-Looking StatementsThis press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Footnote:¹ European Medicines Agency. "Acomplia Suspended as Risks Outweigh Benefits." October 23, 2008. CONTACT:Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
Miami Herald
18-06-2025
- Business
- Miami Herald
MIRA Pharmaceuticals' Lead Drug Candidate Ketamir-2 First Manuscript Accepted for Publication in the Peer-Reviewed Journal Frontiers in Pharmacology
MIAMI, FL / ACCESS Newswire / June 18, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that the first manuscript describing its lead drug candidate Ketamir-2, currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, has been accepted for publication in the peer-reviewed journal Frontiers in Pharmacology. The article, titled "KETAMIR-2, A NEW MOLECULAR ENTITY AND NOVEL KETAMINE ANALOG," authored by Itzchak Angel, Ph.D., MIRA's Chief Scientific Advisor, highlights Ketamir-2's pharmacological differentiation from ketamine and its potential as a next-generation CNS therapeutic. Peer Review Validates Differentiated Pharmacology and Safety Acceptance into Frontiers in Pharmacology provides external scientific validation by independent experts, underscoring the rigor and credibility of MIRA's research. The publication confirms that Ketamir-2 was specifically engineered to overcome limitations associated with ketamine-such as poor oral bioavailability, dissociative side effects, and non-specific receptor binding. Key Highlights from the Publication: Highly Selective, Cleaner Mechanism: Ketamir-2 is a low-affinity NMDA receptor antagonist that selectively targets the NMDA PCP site. Unlike ketamine, Ketamir-2 showed no significant interaction with over 40 other receptors, transporters, or ion channel targets-including dopamine, opioid, serotonin, and monoaminergic systems-highlighting its clean pharmacological profile and reduced off-target Hyperlocomotion, Even at High Doses: In contrast to ketamine, Ketamir-2 did not induce hyperlocomotion in preclinical models-a behavior associated with agitation and schizophrenia-like symptoms-suggesting a favorable neurobehavioral safety Antidepressant and Anxiolytic Activity: In validated behavioral models (Open Field Test, Elevated Plus Maze, Forced Swim Test), Ketamir-2 demonstrated clear anxiolytic and antidepressant-like effects. Ketamine, used as a control, either showed no benefit or limited effect in most Delivery with Efficient Brain Penetration: All studies were conducted via the oral route. Ketamir-2 was shown to cross the blood-brain barrier and is not a substrate for P-glycoprotein, which often limits oral drug delivery to the brain. This may explain Ketamir-2's ability to maintain CNS activity despite its lower NMDA receptor affinity. "We are honored to see our foundational research on Ketamir-2 published in a high-impact scientific journal," said Erez Aminov, CEO of MIRA. "This milestone adds meaningful scientific credibility and supports our confidence in Ketamir-2's differentiated mechanism, favorable safety profile, and broad clinical potential." "This peer-reviewed publication provides clear validation of the differentiated pharmacological profile of Ketamir-2," added Dr. Itzchak Angel, Chief Scientific Advisor. "Its clean pharmacological profile and safety make it a compelling next-generation alternative to ketamine." Clinical and Corporate Updates MIRA also announced that its Phase 1 trial of Ketamir-2 is progressing as planned, with no safety concerns reported to date and dose escalation advancing. The Company expects to initiate a Phase 2a clinical trial in neuropathic pain by year-end 2025, pending regulatory clearance. In addition, the Company is preparing new scientific data submissions and presentations to further support Ketamir-2's clinical development and potential across CNS-related conditions. MIRA also reaffirmed that the acquisition of SKNY Pharmaceuticals, which includes a first-in-class oral CB1/CB2 inverse agonist for obesity and smoking cessation (SKNY-1), is progressing on track. The Company has submitted the required regulatory filings for the merger to the U.S. Securities and Exchange Commission (SEC). The publication will be available upon release at: Cautionary Note Regarding Forward-Looking Statements This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
Associated Press
02-06-2025
- Business
- Associated Press
Telomir Pharmaceuticals to Participate in BIO 2025 in Boston as Company Prepares for IND Submission and Advances Breakthrough Longevity Platform
Company to meet with prospective partners as it accelerates toward IND submission for Telomir-1, with plans to begin human dosing in the first half of 2026 MIAMI, FL / ACCESS Newswire / June 2, 2025 / Telomir Pharmaceuticals, Inc. (Nasdaq:TELO) ('Telomir' or the 'Company'), an emerging leader in age-reversal science, today announced its participation in the BIO International Convention 2025, taking place in Boston, MA from June 16-19, 2025. The Company has scheduled a full week of BIO One-on-One Partnering™ meetings to explore strategic collaborations, licensing opportunities, and potential M&A transactions. Telomir is actively preparing to submit an Investigational New Drug (IND) application by the end of this year for its lead candidate, Telomir-1-a novel small molecule designed to elongate telomeres, regenerate cells, and reverse core mechanisms of biological aging. The Company is gearing up for its pre-IND meeting with the FDA, with the goal of initiating first-in-human dosing in the first half of 2026. As part of its expanding pipeline, Telomir is advancing a rare-disease exploratory and developmental strategy focused on high-need orphan indications where cellular aging plays a central role. These include: The Company plans to meet with the FDA to establish novel clinical endpoints across its rare disease programs, aiming to unlock accelerated development pathways and regulatory flexibility. In parallel, Telomir-1 is also being investigated in autism spectrum disorder, where its potential impact on telomere biology, oxidative stress, neurodegeneration and inflammation may offer a novel therapeutic approach for neurodevelopmental conditions. Beyond rare and neurological disorders, Telomir has achieved significant preclinical success across a range of high-impact therapeutic areas, underscoring the versatility of its platform: 'The breadth of our preclinical data showcases the potential of Telomir-1 not just as a treatment-but as a platform for addressing aging-related and rare diseases at the source,' said Erez Aminov, Chief Executive Officer of Telomir. 'As we prepare for IND submission and for a pre-IND meeting with the FDA, we look forward to connecting with potential partners at BIO to explore licensing and M&A opportunities that can help accelerate our path to the clinic.' Dr. Angel, Chief Scientific Advisor at Telomir, added: 'In all my years in drug development, I've never seen a molecule with this kind of cross-indication potential. The science behind Telomir-1 is remarkable-it's addressing cellular aging at its root, and the preclinical data speak for themselves. What excites me most is how this one molecule may have the power to transform how we treat aging-related, metabolic, and rare genetic diseases across the board.' Cautionary Note Regarding Forward-Looking Statements This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain 'forward-looking statements,' which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1. Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications and safety of Telomir-1. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which is on file with the SEC. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moya [email protected] (786) 396-6723 SOURCE: Telomir Pharmaceuticals, Inc press release
Associated Press
29-05-2025
- Business
- Associated Press
Telomir Pharmaceuticals Confirms Telomir-1 Restores Vision and Retinal Structure in Age-Related Macular Degeneration (AMD) Animal Model Using FDA-Recognized Surrogate Endpoints
A unique oral drug candidate that is shown to restore vision and regenerate the retina in an animal model, addressing a major unmet need in ocular therapeutics MIAMI, FLORIDA / ACCESS Newswire / May 29, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ('Telomir' or the 'Company'), an emerging leader in age-reversal science, today announced compelling preclinical results from a study evaluating its novel oral therapeutic, Telomir-1, in a genetically modified zebrafish model of age-related macular degeneration (AMD). Following a 14-day oral dosing regimen, Telomir-1 reversed central vision response and vision acuity, restored retinal degeneration and architecture, and significantly reduced oxidative stress-achieving improvements across several FDA-recognized surrogate endpoints relevant to AMD. The study utilized the Sen57wrn-/-ND6-/+ zebrafish model, which combines genetic mutations associated with premature aging (WRN), mitochondrial dysfunction (ND6), and chronic senescence (Sen57). These animals exhibit progressive retinal degeneration, visual impairment, and oxidative stress-closely modeling dry AMD and geographic atrophy in humans. Model Transformation: From Degeneration to Recovery Before treatment, the aged (18-month-old) zebrafish demonstrated clear signs of neurodegeneration and visual impairment. Mutant animals showed sluggish, uncoordinated swimming behavior and delayed responses to visual stimuli such as light and movement-evidence of significant vision loss. Microscopic analysis of their retinas revealed approximately 15% total retinal degeneration, affecting several critical layers: In addition to retinal damage, the diseased animals exhibited reactive oxygen species (ROS) levels nearly four times higher than healthy controls-indicating intense oxidative stress-and suffered a 15% mortality rate during the two-week study window. After receiving Telomir-1, treated animals demonstrated marked recovery: Histological cross-sections confirmed Telomir-1's ability to regenerate not only the inner retinal layers, but also additional retinal structures-supporting improved-laminar retinal restoration and function. Collectively, these results demonstrate Telomir-1's ability to restore visual function, reverse retinal degeneration, reduce oxidative stress, and improve survival-all from a short oral treatment regimen. 'This breakthrough reinforces our vision at Telomir: to redefine how we treat age-related diseases by going beyond symptom management and targeting the root mechanisms of degeneration,' said Erez Aminov, Chief Executive Officer of Telomir. 'To our knowledge, no oral drug has ever demonstrated this level of retinal restoration and vision recovery in any AMD model-this is a meaningful leap forward for patients and the field.' 'The preclinical success achieved in this AMD model is truly remarkable,' added Dr. Angel, Chief Scientific Advisor of Telomir. 'Telomir-1 when studied orally, restored both structure and function in the retina, demonstrating not just neuroprotection, but true regenerative capacity-a property rarely seen in ophthalmic drug development.' Cautionary Note Regarding Forward-Looking Statements This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain 'forward-looking statements,' which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1. Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications and safety of Telomir-1. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which is on file with the SEC. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moya [email protected] (786) 396-6723 SOURCE: Telomir Pharmaceuticals, Inc press release
Miami Herald
28-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals to Participate in BIO 2025 in Boston and Highlights Ongoing Progress Across Clinical Program
The company will engage in BIO One-on-One Partnering™ meetings as it advances Phase 1 for Ketamir-2, prepares Phase IIa study in neuropathic pain, and finalizes filings for SKNY acquisition. MIAMI, FL / ACCESS Newswire / May 28, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that it will participate in the BIO International Convention 2025, taking place in Boston, MA from June 16-19, 2025. The Company has a full schedule of BIO One-on-One Partnering™ meetings planned as it explores potential licensing, strategic partnerships, and M&A opportunities. The Company's lead candidate, Ketamir-2, a next-generation oral ketamine analog, is currently undergoing a Phase 1 clinical trial. With the second dosing cohort completed, the Company is now preparing to initiate the third cohort. Building on this momentum, MIRA anticipates initiating a Phase IIa study in neuropathic pain before the end of the year, advancing the development of what the Company believes could be a safe, effective non-opioid alternative for chronic pain management. In addition, MIRA is advancing a series of preclinical studies with Ketamir-2, including models evaluating its potential in PTSD, as well as a topical formulation aimed at treating localized inflammatory pain. The Company is also finalizing regulatory filings related to its acquisition of SKNY Pharmaceuticals, Inc. ("SKNY"), with submission to the U.S. Securities and Exchange Commission (SEC) expected in the coming weeks. SKNY-1, SKNY's primary pharmaceutical candidate, is being developed as an oral therapeutic targeting smoking cessation and obesity, with activity at CB1, CB2, and MAO-B receptors. "Our pipeline is advancing on all fronts, and we are focused on turning this scientific momentum into long-term value for patients and shareholders," said Erez Aminov, Chief Executive Officer of MIRA. "As we move closer to initiating Phase IIa and completing the SKNY transaction, we're actively exploring strategic opportunities to accelerate growth, including licensing and partnerships-especially in areas like chronic pain where non-opioid alternatives like Ketamir-2 are urgently needed." Dr. Angel, Chief Scientific Advisor at MIRA, added:"We believe Ketamir-2 is paving the way for a new class of non-opioid therapies. The science is compelling, and the progress we have made is truly exciting. I look forward to sharing the depth of our work and the promising data we've generated with potential partners and investors." Cautionary Note Regarding Forward-Looking StatementsThis press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact InformationHelga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
