Latest news with #Ketamir-2
Miami Herald
4 days ago
- 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
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
Miami Herald
06-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity
Press Releases MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity Preclinical data supports the advancement of oral Ketamir-2 as a safe, next-generation alternative to ketamine, with ongoing momentum in Phase I clinical trial enrollment MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing breakthrough treatments for neurological and neuropsychiatric conditions, today announced positive results from a neurotoxicity study of Ketamir-2, its novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration (FDA) prior to initiating human dosing in the United States. The preclinical study showed no evidence of brain toxicity, including the absence of Olney lesions-vacuolar brain changes historically associated with older NMDA-targeting drugs such as ketamine and MK-801. These results further confirm the favorable safety profile of Ketamir-2 and support its safe continued clinical development. "These results represent a key milestone in the development of Ketamir-2," said Erez Aminov, Chairman and CEO of MIRA. "The absence of NMDA-linked neurotoxicity, along with continued clinical progress, reinforces our confidence in Ketamir-2's potential as a safe next-generation, oral candidate for CNS disorders." Study Overview and Key Findings The neurotoxicity study was conducted in sexually mature Sprague-Dawley rats. High oral doses of Ketamir-2 were administered, while a positive control group received MK-801, a known neurotoxic NMDA receptor antagonist. Brain tissues were examined through detailed histopathological analysis at two time points. Key outcomes: No adverse clinical signs or mortality in any Ketamir-2-treated animals. No microscopic or macroscopic brain lesions detected at any dose. MK-801-treated animals showed clear evidence of brain toxicity, including vacuolation and neuronal necrosis. "These findings eliminate one of the main safety concerns that has historically limited NMDA-targeting therapies," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Ketamir-2's clean neurotoxicity profile strengthens its position as a differentiated and promising therapeutic candidate." Why Ketamir-2 Stands Apart Ketamir-2 is a New Molecular Entity (NME) designed to modulate the NMDA receptor with a reduced affinity for the PCP binding site, which is strongly associated with neurotoxicity and psychotropic effects in legacy compounds like ketamine. In prior preclinical studies, Ketamir-2 has: Demonstrated full reversal of pain thresholds in validated neuropathic pain models. Outperformed FDA-approved treatments such as gabapentin and pregabalin. Shown no sedation or hyperactivity. Demonstrated strong oral bioavailability and brain penetration, as it is not a substrate for P-glycoprotein (P-gp). Ketamir-2 was designed for oral administration, offering a non-invasive alternative to intravenous therapies. In addition, the U.S. Drug Enforcement Administration (DEA) has determined that Ketamir-2 is not classified as a controlled substance, which may streamline development, reduce regulatory burdens, and improve future access if approved. Clinical Progress and What's Next MIRA has already initiated its Phase I clinical trial, with subject recruitment actively underway and progressing smoothly. The Company is preparing to launch a Phase IIa proof-of-concept trial in diabetic patients with neuropathic pain, with the goal of validating clinical efficacy and supporting future regulatory milestones. The newly completed neurotoxicity study results will be submitted to the FDA as part of MIRA's ongoing regulatory and clinical development strategy. Additional information about MIRA Pharmaceuticals is available 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 Moya info@ (786) 432-9792 SOURCE: MIRA Pharmaceuticals This story was originally published May 6, 2025 at 8:06 AM.
Globe and Mail
16-04-2025
- Business
- Globe and Mail
Pharmaceutical Stock Jumps After Key Trial Findings
A pharmaceuticals company based out of Maryland is turning heads on Wednesday after the company announced that data demonstrated the potential efficacy of its oral ketamine analog, Ketamir-2, in treating diabetic neuropathy in animal model, according to a press release from this morning. Traders wasted little time buying up shares of MIRA Pharmaceuticals Inc. (Nasdaq:MIRA), thrusting the micro cap up to $1.33/share (+48.24%) at the early session high. This move could indicate a breakout is imminent as this stock fights to breakout of a multi-month downtrend. MIRA Pharmaceuticals, Inc. operates as a clinical development stage biopharmaceutical company. The company focuses on the development and commercialization of a new molecular synthetic tetrahydrocannabinol (THC) analog under investigation for the treatment of adult patients with anxiety and cognitive decline typically associated with early-stage dementia. It is developing MIRA1a, a synthetic cannabinoid analog to treat anxiety and chronic pain by targeting the cannabinoid type 1 and type 2 receptors. The company was formerly known as MIRA1a Therapeutics, Inc. MIRA Pharmaceuticals, Inc. was incorporated in 2020 and is headquartered in Baltimore, Maryland. Copyright © 2025 All rights reserved. Republication or redistribution of content is expressly prohibited without the prior written consent of shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. View more of this article on About Media, Inc.: Founded in 1999, is one of North America's leading platforms for micro-cap insights. Catering to both Canadian and U.S. markets, we provide a wealth of resources and expert content designed for everyone—from beginner investors to seasoned traders. is rapidly gaining recognition as a leading authority in the micro-cap space, with our insightful content prominently featured across numerous top-tier financial platforms, reaching a broad audience of investors and industry professionals. Want to showcase your company's story to a powerful network of investors? We can help you elevate your message and make a lasting impact. Contact us today. Contact: Media, Inc.
Yahoo
24-03-2025
- Business
- Yahoo
EXCLUSIVE: MIRA Pharmaceuticals Signs To Acquire SKNY Pharmaceuticals, Expand Pipeline Into Weight Loss And Smoking Cessation Drug
On Monday, MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) signed a binding letter of intent (LOI) to acquire SKNY Pharmaceuticals, Inc. The transaction includes a $5 million capital infusion of cash or equivalent consideration into MIRA, reinforcing its financial position and supporting the advancement of SKNY-1, a preclinical-stage oral drug candidate for weight loss and smoking cessation. Also Read: Under the terms, MIRA will acquire SKNY through a stock exchange, whereby SKNY shareholders will receive shares of MIRA common stock at a valuation determined by an independent third-party firm. Additionally, SKNY will contribute $5 million in cash or assets to MIRA at closing. Upon completion, SKNY-1 and all related intellectual property assets will be fully integrated into MIRA. The acquisition of SKNY Pharmaceuticals strategically positions MIRA to enter two high-growth pharmaceutical markets with a differentiated, next-generation oral therapy. SKNY-1, in preclinical development, is being investigated as a potential oral therapeutic option for metabolic regulation. The drug candidate is designed to interact with cannabinoid receptors CB1 and CB2 pathways that have been demonstrated for their role in appetite, metabolism, and energy balance regulation. SKNY-1 is being developed as a potential oral therapy that may work by modulating cannabinoid pathways involved in nicotine dependence. If successful, it could provide an alternative to existing treatments by addressing key challenges in smoking cessation. Last week, MIRA Pharmaceuticals announced the formulation of Ketamir-2 as a topical treatment for localized neuropathic and inflammatory pain. The advancement expands the company's pain management portfolio beyond its ongoing Ketamir-2 oral treatment for neuropathic pain. Price Action: MIRA stock is trading lower by 3.12% to $1.24 premarket at the last check on Monday. Read Next:Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article EXCLUSIVE: MIRA Pharmaceuticals Signs To Acquire SKNY Pharmaceuticals, Expand Pipeline Into Weight Loss And Smoking Cessation Drug originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
