MIRA Pharmaceuticals Inc【MIRA】株式ニュース

MIRA Pharmaceuticals Announces Acceptance of Peer-Reviewed SKNY-1 Manuscript Highlighting Oral Obesity and Nicotine Addiction Drug CandidateMay 13, 2026 8:00 AM
ACCESS NewswirePeer-reviewed publication highlights preclinical findings demonstrating weight loss, lipid normalization, and reduction of compulsive feeding and nicotine-seeking behaviorsMIAMI, FL / ACCESS Newswire / May 13, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on the development of investigational therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the acceptance and publication of a peer-reviewed manuscript describing the preclinical pharmacology and activity of SKNY-1, the Company's oral investigational drug candidate being evaluated for obesity and nicotine addiction, in the International Journal of Molecular Sciences.The publication, titled "SKNY-1, a THCV Analog, Produces Weight Loss, Lipid Normalization and Attenuation of Reward-Associated Behaviors in an mc4r(G894C) Zebrafish Model of Obesity," describes in vitro pharmacologic characterization and in vivo preclinical findings observed in an MC4R-deficient zebrafish model exhibiting obesity-associated metabolic and reward-related phenotypes.The full publication is available online through MDPI at International Journal of Molecular Sciences publication."Despite significant advances in obesity treatment, existing therapeutic approaches continue to face limitations related to tolerability, long-term adherence, durability of response, and increasing clinical focus on preservation of lean body mass during weight reduction," said Erez Aminov, CEO of MIRA. "We believe the publication of these peer-reviewed findings further supports the differentiated pharmacological profile of SKNY-1 and its potential as a novel oral investigational approach targeting both metabolic and reward-associated pathways."According to the publication, SKNY-1 demonstrated differential engagement of cannabinoid receptor 1 (CB1) signaling pathways, partial agonist activity at cannabinoid receptor 2 (CB2), and selective in vitro inhibition of monoamine oxidase B (MAO-B) relative to MAO-A. The manuscript further reports that oral administration of SKNY-1 in the mc4r(G894C) zebrafish model was associated with dose-dependent reductions in body weight, modulation of lipid parameters, reduction of hepatic triglyceride accumulation, and attenuation of compulsive feeding and nicotine-seeking behaviors.The Company previously reported additional preclinical behavioral findings consistent with SKNY-1's differentiated CB1 pathway engagement, including attenuation of anxiety-like behaviors in a validated zebrafish behavioral model evaluating cannabinoid-related central nervous system effects.Key findings described in the publication include:Dose-dependent reduction in body weight following six days of oral administration, with the higher dose group demonstrating approximately 30% reduction relative to baseline.No significant reduction in whole-body density observed during the treatment period.Reductions in total cholesterol, low-density lipoprotein (LDL), and hepatic triglyceride accumulation relative to untreated mc4r(G894C) controls.Dose-dependent attenuation of high-calorie feeding and nicotine-seeking behaviors in multiple behavioral paradigms.Modulation of appetite-regulatory leptin and ghrelin gene expression patterns toward wild-type levels.The publication also discusses limitations associated with currently available obesity therapies and the potential rationale for evaluating differentiated oral therapeutic approaches targeting both metabolic dysregulation and reward-associated behaviors.Dr. Itzchak Angel, Chief Scientific Advisor at MIRA and corresponding author of the publication, commented:"The manuscript demonstrates coordinated metabolic and behavioral findings observed with SKNY-1 in a validated preclinical obesity model. We believe these data support continued translational investigation of SKNY-1 and further evaluation of its pharmacological profile in future studies."The Company noted that the publication describes short-term preclinical findings in zebrafish models and that additional studies, including mammalian studies, pharmacokinetic evaluations, toxicology studies, and regulatory review, will be required before determining whether SKNY-1 may advance toward clinical development.About SKNY-1SKNY-1 is an orally administered investigational drug candidate designed to modulate multiple pathways associated with metabolic regulation and reward-associated behaviors. The compound was designed to combine pathway-selective CB1 modulation, CB2 receptor activity, and selective MAO-B inhibition. SKNY-1 has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority, and its safety and efficacy have not been established in humans.About MIRA Pharmaceuticals, Inc.MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of investigational therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates being evaluated for neuropathic pain(CIPN), inflammatory pain, obesity, addiction-related disorders, anxiety, and cognitive impairment.For more information, please visit MIRA Pharmaceuticals.Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "can," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "potential," "intend," "seek," "target" and other words of similar meaning, although not all forward-looking statements include these words. Forward-looking statements may include, but are not limited to, statements regarding the therapeutic potential, mechanism of action, development plans, regulatory pathway, safety profile, clinical utility, market opportunity, and future development of SKNY-1 and the Company's other product candidates. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management's beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical development, the ability to obtain regulatory approvals, the outcome of future studies, reliance on third parties, intellectual property protection, financing needs, market conditions, and the other risks identified in the Company's under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K and the Company's other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise such statements, whether as a result of new information, future events or otherwise, except as required by applicable law.We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and in the "Investors" section of our website at mirapharmaceuticals.com/investors/, for a discussion of these and other risks and uncertainties.Contact:
Krystina Quintana

MIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a StudyFebruary 3, 2026 7:30 AM
ACCESS NewswireCompany to Participate in BIO Partnering Summit and Present Phase 1 Ketamir-2 Data at American Association for Cancer Research (AACR)Annual MeetingMIAMI, FLORIDA / ACCESS Newswire / February 3, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today announced that it has initiated dosing in the final cohort of its Phase 1 multiple ascending dose (MAD) clinical trial evaluating Ketamir-2, its lead oral NMDA receptor antagonist.To date, 50 healthy volunteers have already been dosed, while dosing in the final cohort is underway, with 6 last subjects remaining. The Company expects to complete the Phase 1 clinical program by the end of the first quarter of 2026.Phase 1 Progress and Phase 2a Development PlansThe ongoing randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of Ketamir-2 in healthy volunteers. Data reviewed to date continue to support advancement of the program, with no serious adverse events reported.MIRA is actively finalizing its Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy (CIPN), including clinical site selection, and plans to submit the Phase 2a protocol to the U.S. Food and Drug Administration (FDA) following completion of Phase 1. Subject to regulatory feedback, the Company anticipates initiating the Phase 2a study in the second quarter of 2026.Given the oncology-related nature of CIPN, the lack of FDA-approved therapies, and the significant unmet medical need, the Company intends to pursue FDA Fast Track designation for Ketamir-2 as the program advances into later-stage clinical development.Chemotherapy-Induced Peripheral Neuropathy Represents a Significant Unmet Medical NeedChemotherapy-induced peripheral neuropathy is a common and often debilitating complication of cancer treatment, characterized by chronic nerve pain, tingling, numbness, and burning sensations that may persist long after chemotherapy has ended. CIPN can significantly impair quality of life and frequently limits a patient's ability to tolerate or complete potentially lifesaving cancer therapy.Despite its prevalence and clinical impact, there are currently no FDA-approved treatments for CIPN. Management typically relies on off-label use of antidepressants, anticonvulsants, opioids, or ketamine-based therapies, which often provide limited benefit and may be associated with tolerability, safety, or practicality challenges. Ketamir-2 was designed to address this unmet need as a differentiated, orally administered NMDA receptor antagonist with the potential to provide effective pain relief without the psychoactive effects or administration limitations associated with ketamine.Strategic Partnering and Scientific Engagement in 2026As part of its business development strategy, MIRA announced that it will attend the BIO Partnering Investment & Growth Summit, to be held March 2-3, 2026, in Miami, Florida. The Company plans to engage with large and mid-size pharmaceutical companies to introduce its pipeline and advance potential strategic partnership, collaboration, and merger and acquisition discussions.In addition, MIRA will be presenting Phase 1 data on Ketamir-2 at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17-22, 2026, at the San Diego Convention Center in San Diego, California.Pipeline Update Beyond Ketamir-2MIRA also provided an update on its additional preclinical programs, SKNY-1 and MIRA-55, both of which are currently undergoing CMC optimization, with the objective of advancing each program into IND-enabling status by year-end 2026.SKNY-1 is a novel, orally administered small-molecule program being developed for weight loss and nicotine addiction. SKNY-1 was designed as an oral therapy intended to avoid the central nervous system-related adverse effects historically associated with prior CB1 receptor antagonists, as well as the muscle loss that has been reported with certain injectable GLP-1-based therapies. Preclinical studies to date support its continued development as a differentiated metabolic and addiction-focused candidate.MIRA-55 is a preclinical program being developed for inflammatory pain. In preclinical models, MIRA-55 has demonstrated analgesic activity comparable to injected morphine, along with a significant reduction in inflammation. In these studies, MIRA-55 also demonstrated anti-inflammatory effects that outperformed morphine, supporting its potential as a non-opioid approach to inflammatory pain management.Management Commentary"We are pleased to have initiated dosing in the final cohort of our Phase 1 study, marking another important execution milestone for Ketamir-2," said Erez Aminov, Chairman and CEO of MIRA. "As we approach completion of Phase 1 and prepare for Phase 2a development in CIPN, we are increasingly focused on advancing partnering discussions while continuing disciplined, data-driven execution across our pipeline."Dr. Itzchak Angel, CSA of MIRA, added:"Chemotherapy-induced neuropathic pain remains an area of profound unmet medical need, with no approved therapies and limited effective options for patients. Ketamir-2 was specifically designed to offer a safer, orally administered alternative that targets key pain pathways without the limitations associated with existing treatments. Advancing this program represents an important step toward improving supportive care for oncology patients."About Ketamir-2Ketamir-2 is a proprietary, orally bioavailable new molecular entity designed as a next-generation NMDA receptor antagonist. Preclinical and early clinical data support its potential as an oral, non-opioid therapy for neuropathic pain and related conditions. Ketamir-2 is not classified as a controlled substance under the U.S. Controlled Substances Act.About MIRA Pharmaceuticals, Inc.MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications with significant unmet medical need.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 www.sec.gov and on MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.Contact:
Krystina Quintana