Latest news with #MIRAPharmaceuticals
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
Associated Press
11-07-2025
- Health
- Associated Press
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 MIAMI, FL / ACCESS Newswire / July 11, 2025 / 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: 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: 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 [email protected] (786) 432-9792 SOURCE: MIRA Pharmaceuticals press release
Miami Herald
03-07-2025
- Business
- Miami Herald
MIRA Reports Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid Risks
With Mira-55 and Ketamir-2, MIRA is advancing complementary non-opioid therapies for two of the largest pain markets MIAMI, FLORIDA / ACCESS Newswire / July 3, 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 positive preclinical data demonstrating that Mira-55, the Company's proprietary non-psychotropic marijuana analog, delivered morphine-comparable pain relief in a validated model of inflammatory pain-without causing local inflammation. Mira-55 is a next-generation analog of marijuana, engineered to selectively activate CB2 cannabinoid receptors, which are associated with anti-inflammatory and analgesic effects. Unlike THC, Mira-55 minimizes activation of CB1 receptors, reducing the risk of euphoria, sedation, and pro-inflammatory side effects. "These results reinforce the value of Mira-55 as a differentiated cannabinoid-based therapy with real clinical potential," said Erez Aminov, Chairman and CEO of MIRA. "We believe the drug's ability to match morphine's pain relief-without the baggage of addiction, sedation, or THC-like effects-makes Mira-55 an ideal candidate for large, underserved inflammatory pain markets. It's another step in building a non-opioid pain franchise that addresses both inflammatory and neuropathic pain." Study Overview and Key Findings Mira-55 was tested using the formalin model, a gold-standard preclinical method for studying inflammatory pain. In this model, formalin is injected into the rat's paw, producing a pain response that mimics human inflammatory pain. Pain sensitivity was assessed using Von Frey Filament testing, which measures tactile pain thresholds, and inflammation was measured by paw edema volume. Key findings: Mira-55 reduced pain sensitivity by approximately threefold, restoring thresholds to near-baseline analgesic effect was equivalent to morphine, the standard opioid comparator in the sedation or inflammatory swelling was observed with Mira-55 treatment. Importantly, following a scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not classified as a controlled substance. This designation supports the compound's long-term clinical and commercial viability and removes key barriers typically associated with cannabinoid-based drug development. These results build on prior data from a separate inflammatory pain model conducted by a leading U.S. academic research center, where Mira-55 blocked both thermal and mechanical hyperalgesia without increasing inflammation. In contrast, low-dose THC in that model exacerbated inflammation-further validating Mira-55's selective pharmacological profile. "Mira-55 offers the pain-relieving potential of cannabinoids without the liabilities traditionally seen in THC-based drugs," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Its novel structure and unique profile with CB2 selectivity and non-scheduled DEA status make it a compelling candidate for treating inflammation-driven pain conditions that are poorly managed by today's standards." Strategic Fit Within MIRA's Pain Portfolio Mira-55 complements Ketamir-2, MIRA's clinical-stage NMDA receptor antagonist, which is advancing through Phase 1 development for neuropathic pain. While Ketamir-2 addresses nerve-related pain through central mechanisms, Mira-55 targets inflammatory pain through the endocannabinoid system. Together, they represent two mechanistically distinct, non-opioid approaches to treating chronic pain. "With Mira-55 and Ketamir-2, we now have two highly differentiated drug candidates with the potential to transform how inflammatory and neuropathic conditions are treated," added Aminov. "We're advancing each asset methodically, and we're energized by the momentum we've built across the pipeline." Corporate Update on SKNY Merger MIRA also announced continued progress on its previously disclosed acquisition of SKNY Pharmaceuticals, the developer of SKNY-1, a novel investigational therapy targeting both obesity and nicotine addiction. In recent studies, SKNY-1 demonstrated a 30% reduction in body weight without muscle loss, along with a reversal of nicotine cravings-highlighting its potential as a differentiated treatment in two major markets. The U.S. Securities and Exchange Commission (SEC) has completed its review of the merger proxy with no comments, allowing MIRA to proceed with shareholder approval and the final steps toward completing the transaction. "We are pleased to report that the SEC had no comments on our merger filing, which reflects the quality of our regulatory and business preparation," said Aminov. "This milestone allows us to advance toward shareholder approval with clarity and confidence as we prepare for the next phase of growth." Next Steps MIRA Pharmaceuticals is advancing Mira-55 toward an Investigational New Drug (IND) submission, with ongoing activities supporting future clinical development in inflammatory pain. The Company remains focused on progressing both lead programs-Mira-55 and Ketamir-2-toward their next regulatory and clinical milestones. 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 neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline. 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 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
USA Today
03-07-2025
- Business
- USA Today
MIRA Reports Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid Risks
With Mira-55 and Ketamir-2, MIRA is advancing complementary non-opioid therapies for two of the largest pain markets 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 positive preclinical data demonstrating that Mira-55, the Company's proprietary non-psychotropic marijuana analog, delivered morphine-comparable pain relief in a validated model of inflammatory pain-without causing local inflammation. Mira-55 is a next-generation analog of marijuana, engineered to selectively activate CB2 cannabinoid receptors, which are associated with anti-inflammatory and analgesic effects. Unlike THC, Mira-55 minimizes activation of CB1 receptors, reducing the risk of euphoria, sedation, and pro-inflammatory side effects. 'These results reinforce the value of Mira-55 as a differentiated cannabinoid-based therapy with real clinical potential,' said Erez Aminov, Chairman and CEO of MIRA. 'We believe the drug's ability to match morphine's pain relief-without the baggage of addiction, sedation, or THC-like effects-makes Mira-55 an ideal candidate for large, underserved inflammatory pain markets. It's another step in building a non-opioid pain franchise that addresses both inflammatory and neuropathic pain.' Study Overview and Key Findings Mira-55 was tested using the formalin model, a gold-standard preclinical method for studying inflammatory pain. In this model, formalin is injected into the rat's paw, producing a pain response that mimics human inflammatory pain. Pain sensitivity was assessed using Von Frey Filament testing, which measures tactile pain thresholds, and inflammation was measured by paw edema volume. Key findings: Mira-55 reduced pain sensitivity by approximately threefold, restoring thresholds to near-baseline levels. Its analgesic effect was equivalent to morphine, the standard opioid comparator in the study. No sedation or inflammatory swelling was observed with Mira-55 treatment. Importantly, following a scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not classified as a controlled substance. This designation supports the compound's long-term clinical and commercial viability and removes key barriers typically associated with cannabinoid-based drug development. These results build on prior data from a separate inflammatory pain model conducted by a leading U.S. academic research center, where Mira-55 blocked both thermal and mechanical hyperalgesia without increasing inflammation. In contrast, low-dose THC in that model exacerbated inflammation-further validating Mira-55's selective pharmacological profile. 'Mira-55 offers the pain-relieving potential of cannabinoids without the liabilities traditionally seen in THC-based drugs,' said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. 'Its novel structure and unique profile with CB2 selectivity and non-scheduled DEA status make it a compelling candidate for treating inflammation-driven pain conditions that are poorly managed by today's standards.' Strategic Fit Within MIRA's Pain Portfolio Mira-55 complements Ketamir-2, MIRA's clinical-stage NMDA receptor antagonist, which is advancing through Phase 1 development for neuropathic pain. While Ketamir-2 addresses nerve-related pain through central mechanisms, Mira-55 targets inflammatory pain through the endocannabinoid system. Together, they represent two mechanistically distinct, non-opioid approaches to treating chronic pain. 'With Mira-55 and Ketamir-2, we now have two highly differentiated drug candidates with the potential to transform how inflammatory and neuropathic conditions are treated,' added Aminov. 'We're advancing each asset methodically, and we're energized by the momentum we've built across the pipeline.' Corporate Update on SKNY Merger MIRA also announced continued progress on its previously disclosed acquisition of SKNY Pharmaceuticals, the developer of SKNY-1, a novel investigational therapy targeting both obesity and nicotine addiction. In recent studies, SKNY-1 demonstrated a 30% reduction in body weight without muscle loss, along with a reversal of nicotine cravings-highlighting its potential as a differentiated treatment in two major markets. The U.S. Securities and Exchange Commission (SEC) has completed its review of the merger proxy with no comments, allowing MIRA to proceed with shareholder approval and the final steps toward completing the transaction. 'We are pleased to report that the SEC had no comments on our merger filing, which reflects the quality of our regulatory and business preparation,' said Aminov. 'This milestone allows us to advance toward shareholder approval with clarity and confidence as we prepare for the next phase of growth.' Next Steps MIRA Pharmaceuticals is advancing Mira-55 toward an Investigational New Drug (IND) submission, with ongoing activities supporting future clinical development in inflammatory pain. The Company remains focused on progressing both lead programs-Mira-55 and Ketamir-2-toward their next regulatory and clinical milestones. 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
Associated Press
28-05-2025
- Business
- Associated Press
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 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 Moya [email protected] (786) 432-9792 SOURCE: MIRA Pharmaceuticals press release
