Core Insights - MIRA Pharmaceuticals has initiated dosing in the final cohort of its Phase 1 clinical trial for Ketamir-2, an oral NMDA receptor antagonist, with plans to complete the trial by the end of Q1 2026 [1] - The company is preparing for a Phase 2a study targeting chemotherapy-induced peripheral neuropathy (CIPN) and aims to submit the protocol to the FDA after completing Phase 1 [1] - MIRA plans to pursue FDA Fast Track designation for Ketamir-2 due to the significant unmet medical need in CIPN treatment [1] Phase 1 Progress and Phase 2a Development Plans - The ongoing Phase 1 study is randomized, double-blind, and placebo-controlled, focusing on safety, tolerability, and pharmacokinetics of Ketamir-2 [1] - So far, 50 healthy volunteers have been dosed, with 6 subjects remaining in the final cohort [1] - No serious adverse events have been reported, supporting the advancement of the program [1] - The Phase 2a study is expected to begin in Q2 2026, pending regulatory feedback [1] Unmet Medical Need in CIPN - CIPN is a common complication of cancer treatment, leading to chronic nerve pain and significantly impairing quality of life [1] - There are currently no FDA-approved treatments for CIPN, with management relying on off-label therapies that often provide limited benefits [1] - Ketamir-2 aims to offer a safer, orally administered alternative without the psychoactive effects associated with existing treatments [1] Strategic Partnering and Scientific Engagement - MIRA will attend the BIO Partnering Investment & Growth Summit in March 2026 to engage with pharmaceutical companies for potential partnerships [1] - The company will present Phase 1 data on Ketamir-2 at the AACR Annual Meeting in April 2026 [1] Pipeline Update Beyond Ketamir-2 - MIRA is also developing two preclinical programs, SKNY-1 and MIRA-55, both undergoing CMC optimization [1] - SKNY-1 targets weight loss and nicotine addiction, designed to avoid CNS-related adverse effects [1] - MIRA-55 has shown analgesic activity comparable to morphine and significant anti-inflammatory effects in preclinical models [1]