MIRA News & Events

MIRA Pharmaceuticals announced completion of dosing in its Phase 1 clinical trial evaluating Ketamir-2, the Company's proprietary selective oral NMDA receptor modulator. The randomized, double-blind, placebo-controlled study enrolled 56 healthy adult volunteers across single ascending dose and multiple ascending dose cohorts. Based on safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported at any dose level tested. In addition, no clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed. Database lock, unblinding, and final audited pharmacokinetic and safety analyses are underway. Phase 1 data have been accepted for presentation at the upcoming American Association for Cancer Research Annual Meeting.

MIRA Pharmaceuticals initiated dosing in the final cohort of its Phase 1 multiple ascending dose clinical trial evaluating Ketamir-2, its lead oral NMDA receptor antagonist. To date, 50 healthy volunteers have already been dosed, while dosing in the final cohort is underway, with 6 last subjects remaining. The Company expects to complete the Phase 1 clinical program by the end of the first quarter of 2026. The ongoing randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of Ketamir-2 in healthy volunteers. Data reviewed to date continue to support advancement of the program, with no serious adverse events reported. MIRA is actively finalizing its Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy, including clinical site selection, and plans to submit the Phase 2a protocol to the U.S. Food and Drug Administration following completion of Phase 1. Subject to regulatory feedback, the Company anticipates initiating the Phase 2a study in the second quarter of 2026. Given the oncology-related nature of CIPN, the lack of FDA-approved therapies, and the significant unmet medical need, the Company intends to pursue FDA Fast Track designation for Ketamir-2 as the program advances into later-stage clinical development.