MIRA Pharmaceuticals Inc. filed SEC Form 8-K: Other Events
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Item 8.01 Other Events
MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity
On May 6, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced the completion of a regulatory-required neurotoxicity study of Ketamir-2, the Company’s novel oral NMDA receptor antagonist. The study was conducted in accordance with FDA guidance as part of the Company’s ongoing clinical development program.
The study evaluated the potential for Ketamir-2 to produce neuropathologic changes, including Olney lesions, which have historically been associated with certain NMDA receptor antagonists such as ketamine and MK-801. The study was conducted in sexually mature Sprague-Dawley rats. Animals were administered high oral doses of Ketamir-2, while a separate positive control group received MK-801. All animals were observed for clinical signs and underwent detailed histopathological brain analysis at two timepoints.
Key findings from the study include:
| ● | No test article-related mortality or adverse clinical signs were observed in animals treated with Ketamir-2. | |
| ● | No microscopic or macroscopic brain lesions were detected in Ketamir-2-treated groups. | |
| ● | Positive control animals treated with MK-801 showed clear evidence of vacuolation and neuronal necrosis, consistent with Olney-type lesions. |
The results of the study indicate that Ketamir-2 did not induce neurotoxic changes under the study conditions.
These findings will be submitted to the U.S. Food and Drug Administration (FDA) as part of MIRA’s ongoing regulatory communications.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIRA PHARMACEUTICALS, INC. | ||
| Dated: May 6, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |