Mira Pharma completes Ketamir-2 GLP safety program; no adverse findings, IND submission by year-end 2024

MIRA PHARMACEUTICALS, INC.

Successful completion of GLP preclinical safety program for Ketamir-2; no adverse findings across cardiovascular, CNS, respiratory, and toxicology studies.
Key results: cardiovascular safety in dogs, CNS assessment in rats (transient high-dose effects), 14-day dog tox up to 200 mg/kg, Ames test non-mutagenic.
Plan to submit IND by end of 2024; Phase I trial start Q1 2025 for safety, tolerability, PK/PD, and pain evaluation.
Early Phase I data expected Q2 2025; focus on neuropathic pain and psychosis.

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