Latest news with #SKNY-1
USA Today
11-07-2025
- Health
- USA Today
MIRA Reports Clear Reversal of Anxiety-Related Behavior in Animal Model Using SKNY-1, an Oral Drug Candidate for Obesity and Nicotine Addiction Under Definitive Agreement for Acquisition
SKNY-1 was previously shown to achieve up to 30% weight loss, reverse nicotine craving, and preserve muscle mass in an animal model-and is designed to avoid the CNS side effects that halted earlier CB1-targeting drugs MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) today announced new preclinical results from SKNY-1, an oral drug candidate for obesity and nicotine addiction currently under definitive agreement for acquisition. In a validated behavioral model used to measure Cannabinoid 1 receptor (CB1) related anxiety-like effects, SKNY-1 demonstrated clear reversal of anxiety-related behavior induced by a CB1 activator, setting it apart from earlier CB1-targeting drugs that were discontinued due to serious central nervous system (CNS) effects. SKNY-1 is being developed as a potential oral treatment for obesity and addiction. It has previously been shown to achieve up to 30% weight loss, reverse high-calorie food and nicotine cravings, and preserve muscle mass in preclinical models. These new findings suggest that SKNY-1 may deliver these therapeutic effects without emotional or behavioral disruption, an important factor in long-term treatment adherence. 'These findings are a significant step forward,' said Erez Aminov, Chief Executive Officer of MIRA. 'The ability to suppress appetite and cravings while reversing anxiety-like effects is critical. These results reinforce the differentiated approach behind SKNY-1 and its potential role as a novel oral treatment in large, underserved markets.' About the Study The study used the light-dark preference test in zebrafish-a validated behavioral model to assess anxiety-related responses. Zebrafish naturally prefer darker environments due to an innate fear of predators. However, when anxiety levels are elevated, they avoid the light even more strongly spending more time in the dark. Reduced dark preference (i.e., more time in the light) is interpreted as a calming effect. Four groups were evaluated: Control Group (No Drug): Fish showed balanced behavior between light and dark environments. CP55,940 Group (CB1 Agonist): These animals spent significantly more time in the dark, confirming that CB1 activation increases anxiety at higher doses. Interestingly, at lower doses, CP55,940 produced a calming effect-reducing dark preference and encouraging exploration of the light area. Rimonabant Group (CB1 Inverse Agonist): Fish treated with Rimonabant also showed increased dark-zone time and exhibited a greater increase in anxiety-like behavior than the CB1 agonist group, under both high and low doses of agonist-consistent with the known psychiatric effects that led to Rimonabant's market withdrawal. SKNY-1 Groups: In animals co-treated with CP55,940, SKNY-1 significantly reversed the anxiety-inducing effects of high-dose CP55,940 and enhanced the calming effects at low doses. In all conditions, SKNY-1 brought anxiety-like behavior back to control or better-than-control levels. These results suggest SKNY-1 may help stabilize mood and stress-related behavior-a potential advantage in treating both metabolic and addictive disorders. A New Approach to Endocannabinoid Modulation SKNY-1 targets the endocannabinoid system (ECS)-a key regulator of hunger, emotion, reward, and addictive behavior-through a multi-pathway approach: Biased CB1 antagonism blocks β-arrestin signaling (linked to cravings and compulsive behavior) while preserving G-protein signaling (important for emotional regulation). CB2 partial agonism may reduce inflammation in the brain, which is increasingly recognized as a driver of anxiety, depression, and cognitive decline. By lowering neuroinflammation, SKNY-1 may help preserve emotional balance and support cognitive resilience. Mild inhibition of MAO-B regulates dopamine, which plays a role in motivation and behavioral control. No inhibition of MAO-A confirmed through in vitro screening-important because MAO-A inhibitors are associated with mood instability, drug interactions, and safety concerns. This multi-target profile gives SKNY-1 a differentiated mechanism that may allow it to reduce cravings and weight while supporting emotional health-without the psychiatric side effects that limited earlier CB1 or MAO-based drugs. 'The ability to block cravings while preserving emotional balance is a key challenge in this field,' said Dr. Itzchak Angel, MIRA's Chief Scientific Advisor. 'SKNY-1 appears to meet that challenge head-on. The demonstration that its profile is significantly different than rimonabant in its interaction with CB1 agonists, reinforces the unique pharmacological profile of the drug.' Market Opportunity Obesity and addiction are among the most urgent and expensive public health challenges globally. In the U.S. alone, the economic burden of obesity and related chronic diseases is estimated at $1.7 trillion annually, equivalent to over 9% of the nation's GDP (Milken Institute, 2023). Yet despite significant commercial investment, current therapies remain limited by efficacy gaps and tolerability challenges. Current GLP‑1 therapies like semaglutide deliver weight loss but are injectables, often cause gastrointestinal side effects, and can result in loss of lean muscle mass. Smoking cessation therapies such as varenicline or bupropion offer modest long-term success and may carry psychiatric warnings that restrict their use in sensitive patient populations. Earlier CB1-targeting drugs, including rimonabant, were withdrawn due to severe mood disorders. Furthermore, broad MAO inhibition-especially MAO‑A-has long been associated with mood instability and dangerous food-drug interactions. SKNY‑1 was developed to address those limitations directly. With oral administration, differentiated pharmacology, and potential dual efficacy in obesity and nicotine addiction, SKNY‑1 may offer a best-in-class profile. Its lack of MAO‑A inhibition, confirmed in vitro, further enhances its therapeutic promise. Next Steps MIRA is currently preparing for shareholder approval related to the proposed acquisition of SKNY Pharmaceuticals, Inc. Pending approval, the Company expects to initiate Investigational New Drug (IND)-enabling studies for SKNY-1 as a next step toward human clinical trials. About MIRA Pharmaceuticals, Inc. MIRA 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 neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline. 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 the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at and on MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact: Helga Moya info@ (786) 432-9792 SOURCE: MIRA Pharmaceuticals View the original press release on ACCESS Newswire
Indianapolis Star
30-06-2025
- Health
- Indianapolis Star
MIRA Reports Up to 30% Weight Loss and Reversal of High-Calorie and Nicotine Cravings in an Animal Model of Obesity and Craving Using SKNY-1, a Drug Candidate Under Definitive Agreement for Acquisition
Oral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss MIAMI, FLORIDA / ACCESS Newswire MIRA (NASDAQ:MIRA) today announced new animal study results from SKNY-1, a next-generation oral therapeutic under definitive agreement for acquisition. In a zebrafish model that mimics human obesity and craving behaviors, SKNY-1 demonstrated weight loss, suppression of appetite and craving for high-calorie diets, and reversal of nicotine-seeking behavior-all achieved within six days of oral treatment. SKNY-1 is being developed as an oral alternative to GLP-1 injectables, which are often limited by nausea, GI discomfort, injection reaction, and growing concerns around muscle loss. Unlike GLP-1s, which reduce both fat and lean mass, SKNY-1 demonstrated significant weight loss with preserved muscle. It was specifically designed to minimize engagement with central nervous system pathways implicated in the psychiatric side effects observed in some smoking cessation therapies and first-generation CB1-targeting weight-loss drugs. The data support SKNY-1's potential as a differentiated oral therapy addressing two of the world's leading causes of preventable death. The study was conducted in an obesity and craving model in Ob42 Strain-mc4r (G894C) mutated zebrafish following six days of oral treatment with two doses of SKNY-1 and was compared to normal controls. Key Results Weight Loss and Muscle Preservation: SKNY-1 reduced body weight by approximately 30% after just six days of oral treatment. Treated animals ended up weighing about 10% less than healthy controls. Importantly, this weight loss was not accompanied by muscle density changes-suggesting SKNY-1 helps burn fat while preserving lean body mass. Metabolic Activity and Ventilation Rate: Treated animals showed an increase in breathing rate, which is a reliable signal that their metabolism was speeding up. This aligns with the observed weight loss and suggests that SKNY-1 helps the body burn more energy. Liver and Lipid Profile Improvements: In untreated obese animals, fat buildup in the liver was about 50% higher than normal. SKNY-1 reversed this buildup, bringing liver fat back to healthy levels. At the same time, cholesterol levels-including LDL ('bad' cholesterol) and HDL ('good' cholesterol)-also returned to normal, without affecting fat levels in the blood. This points to improved fat processing without disrupting the body's overall metabolic balance. Appetite, Craving, and Compulsive Eating: Obese animals were eating 2-3 times more high-calorie food than normal. SKNY-1 dose-dependently reduced this behavior-high-dose animals ate less than healthy controls. The drug also made the animals less likely to pursue food in stressful environments and reduced obsessive food-seeking in tests designed to measure craving. Nicotine Craving and Compulsivity: SKNY-1 significantly reduced the desire to seek out and consume nicotine. Treated animals were less willing to pursue nicotine even in stressful conditions, and they no longer showed a preference for environments linked to nicotine rewards. At the high dose, their behavior matched that of healthy animals with no nicotine craving. Neurohormonal Balance: Obese animals had extremely high levels of leptin (a hunger-regulating hormone) and unusually low levels of ghrelin (the 'hunger signal'). This imbalance often leads to constant hunger and poor appetite control. SKNY-1 normalized both hormones, improving the body's ability to regulate hunger and energy use. Brain Dopamine Regulation: Obese animals had too much dopamine in the brain, likely tied to increased reward and cravings. SKNY-1 reduced these dopamine levels-but only at the lower dose. The high dose did not affect dopamine, suggesting the drug can reduce craving without overstimulating the brain. 'Within just six days, we saw robust behavioral, hormonal and metabolic changes, including weight loss, improved fat metabolism, and reversal of craving-like behaviors,' said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. 'These results highlight SKNY-1's potential to address both obesity and nicotine addiction through unique and safe pathways.' A Differentiated Approach to Two Major Markets Current weight-loss therapies like semaglutide and tirzepatide are effective but limited by gastrointestinal side effects, injectable administration, and loss of lean mass. Smoking cessation treatments such as varenicline and bupropion carry psychiatric warnings and offer modest long-term quit rates. SKNY-1 was designed to overcome these limitations. It selectively modulates CB1 receptors by blocking β-arrestin signaling-associated with cravings and compulsive behavior-while preserving G-protein signaling, which supports emotional and cognitive stability. The compound also activates CB2 receptors and mildly inhibits MAO-B without affecting MAO-A, supporting a favorable safety and tolerability profile. 'These results position SKNY-1 as a potentially disruptive oral treatment,' said Erez Aminov, CEO of MIRA. 'Its ability to reduce body mass, suppress cravings, and preserve muscle-all through oral administration-makes it a compelling therapeutic candidate as we move toward closing the acquisition and preparing for IND-enabling studies.' The Company believes these findings further support the advancement of SKNY-1 toward Investigational New Drug (IND)-enabling studies. With obesity and smoking representing two of the leading causes of preventable death-and a combined global market opportunity exceeding $200 billion-MIRA intends to prioritize SKNY-1 as a potential cornerstone asset pending completion of the acquisition of SKNY Pharmaceuticals, Inc. About MIRA Pharmaceuticals, Inc. MIRA 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 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 the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at and on MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. SOURCE: MIRA Pharmaceuticals View the original press release on ACCESS Newswire
Miami Herald
30-06-2025
- Health
- Miami Herald
MIRA Reports Up to 30% Weight Loss and Reversal of High-Calorie and Nicotine Cravings in an Animal Model of Obesity and Craving Using SKNY-1, a Drug Candidate Under Definitive Agreement for Acquisition
Oral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss MIAMI, FLORIDA / ACCESS Newswire / June 30, 2025 / MIRA (NASDAQ:MIRA) today announced new animal study results from SKNY-1, a next-generation oral therapeutic under definitive agreement for acquisition. In a zebrafish model that mimics human obesity and craving behaviors, SKNY-1 demonstrated weight loss, suppression of appetite and craving for high-calorie diets, and reversal of nicotine-seeking behavior-all achieved within six days of oral treatment. SKNY-1 is being developed as an oral alternative to GLP-1 injectables, which are often limited by nausea, GI discomfort, injection reaction, and growing concerns around muscle loss. Unlike GLP-1s, which reduce both fat and lean mass, SKNY-1 demonstrated significant weight loss with preserved muscle. It was specifically designed to minimize engagement with central nervous system pathways implicated in the psychiatric side effects observed in some smoking cessation therapies and first-generation CB1-targeting weight-loss drugs. The data support SKNY-1's potential as a differentiated oral therapy addressing two of the world's leading causes of preventable death. The study was conducted in an obesity and craving model in Ob42 Strain-mc4r (G894C) mutated zebrafish following six days of oral treatment with two doses of SKNY-1 and was compared to normal controls. Key Results Weight Loss and Muscle Preservation:SKNY-1 reduced body weight by approximately 30% after just six days of oral treatment. Treated animals ended up weighing about 10% less than healthy controls. Importantly, this weight loss was not accompanied by muscle density changes-suggesting SKNY-1 helps burn fat while preserving lean body mass. Metabolic Activity and Ventilation Rate:Treated animals showed an increase in breathing rate, which is a reliable signal that their metabolism was speeding up. This aligns with the observed weight loss and suggests that SKNY-1 helps the body burn more energy. Liver and Lipid Profile Improvements:In untreated obese animals, fat buildup in the liver was about 50% higher than normal. SKNY-1 reversed this buildup, bringing liver fat back to healthy levels. At the same time, cholesterol levels-including LDL ('bad' cholesterol) and HDL ('good' cholesterol)-also returned to normal, without affecting fat levels in the blood. This points to improved fat processing without disrupting the body's overall metabolic balance. Appetite, Craving, and Compulsive Eating:Obese animals were eating 2-3 times more high-calorie food than normal. SKNY-1 dose-dependently reduced this behavior-high-dose animals ate less than healthy controls. The drug also made the animals less likely to pursue food in stressful environments and reduced obsessive food-seeking in tests designed to measure craving. Nicotine Craving and Compulsivity:SKNY-1 significantly reduced the desire to seek out and consume nicotine. Treated animals were less willing to pursue nicotine even in stressful conditions, and they no longer showed a preference for environments linked to nicotine rewards. At the high dose, their behavior matched that of healthy animals with no nicotine craving. Neurohormonal Balance:Obese animals had extremely high levels of leptin (a hunger-regulating hormone) and unusually low levels of ghrelin (the 'hunger signal'). This imbalance often leads to constant hunger and poor appetite control. SKNY-1 normalized both hormones, improving the body's ability to regulate hunger and energy use. Brain Dopamine Regulation:Obese animals had too much dopamine in the brain, likely tied to increased reward and cravings. SKNY-1 reduced these dopamine levels-but only at the lower dose. The high dose did not affect dopamine, suggesting the drug can reduce craving without overstimulating the brain. "Within just six days, we saw robust behavioral, hormonal and metabolic changes, including weight loss, improved fat metabolism, and reversal of craving-like behaviors," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "These results highlight SKNY-1's potential to address both obesity and nicotine addiction through unique and safe pathways." A Differentiated Approach to Two Major Markets Current weight-loss therapies like semaglutide and tirzepatide are effective but limited by gastrointestinal side effects, injectable administration, and loss of lean mass. Smoking cessation treatments such as varenicline and bupropion carry psychiatric warnings and offer modest long-term quit rates. SKNY-1 was designed to overcome these limitations. It selectively modulates CB1 receptors by blocking β-arrestin signaling-associated with cravings and compulsive behavior-while preserving G-protein signaling, which supports emotional and cognitive stability. The compound also activates CB2 receptors and mildly inhibits MAO-B without affecting MAO-A, supporting a favorable safety and tolerability profile. "These results position SKNY-1 as a potentially disruptive oral treatment," said Erez Aminov, CEO of MIRA. "Its ability to reduce body mass, suppress cravings, and preserve muscle-all through oral administration-makes it a compelling therapeutic candidate as we move toward closing the acquisition and preparing for IND-enabling studies." The Company believes these findings further support the advancement of SKNY-1 toward Investigational New Drug (IND)-enabling studies. With obesity and smoking representing two of the leading causes of preventable death-and a combined global market opportunity exceeding $200 billion-MIRA intends to prioritize SKNY-1 as a potential cornerstone asset pending completion of the acquisition of SKNY Pharmaceuticals, Inc. About MIRA Pharmaceuticals, Inc. MIRA 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 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 the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at and on MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact:Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
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
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
