Mira Pharmaceuticals initiates MAD Phase 1 study of oral ketamir-2

MIRA Pharmaceuticals (MIRA) announced the initiation of the multiple ascending dose portion of its ongoing Phase 1 clinical trial evaluating its lead oral candidate, Ketamir-2, in healthy volunteers. The Company also announced that it has selected chemotherapy-induced peripheral neuropathy – a common and debilitating side effect of cancer treatment – as the lead indication for its planned Phase 2a clinical evaluation. This milestone follows the completion of dosing in the single ascending dose portion of the study. According to data reviewed to date, no serious or dose-limiting adverse events have been observed, and no clinically significant safety concerns have been reported. Comprehensive pharmacokinetic analyses will be performed following unblinding to further characterize Ketamir-2’s absorption and half-life profile. The ongoing randomized, double-blind, placebo-controlled Phase 1 study is evaluating single and multiple oral doses of Ketamir-2 to assess its safety, tolerability, and pharmacokinetics in healthy volunteers. The MAD portion includes three cohorts of repeat daily oral dosing, building on the safety and PK data from the SAD phase.