MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity

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[{"type":"text","content":"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","length":170,"tagName":"p"},{"type":"text","content":"MIAMI, FL / ACCESS Newswire / May 6, 2025 / 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.","length":507,"tagName":"p"},{"type":"text","content":"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.","length":331,"tagName":"p"},{"type":"text","content":""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."","length":338,"tagName":"p"},{"type":"text","content":"Study Overview and Key Findings","length":31,"tagName":"p"},{"type":"text","content":"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.","length":310,"tagName":"p"},{"type":"text","content":"Key outcomes:","length":13,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"No adverse clinical signs or mortality in any Ketamir-2-treated animals.","length":72,"tagName":"p"}]},{"val":[{"type":"text","content":"No microscopic or macroscopic brain lesions detected at any dose.","length":65,"tagName":"p"}]},{"val":[{"type"...

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