Mira Pharmaceuticals announces approval, initiation of Phase 1 Ketamir-2 trial

MIRA Pharmaceuticals (MIRA) announced the approval and upcoming initiation of its Phase 1 clinical trial for Ketamir-2, the Company’s novel oral ketamine analog in development for neuropathic pain, with subject recruitment scheduled to begin in Q1 2025. The study has received authorization from the Israeli Ministry of Health and the Institutional Review Board and will be conducted at the Clinical Pharmacology Unit, Hadassah Medical Center in Jerusalem, Israel. This Phase 1, randomized, double-blind, placebo-controlled, single-center study is designed to evaluate the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2 in healthy adult volunteers. The trial consists of two parts: Single Ascending Dose Part: 32 participants; Multiple Ascending Dose Part: 24 participants. In addition to assessing the frequency and severity of adverse events and serious adverse events, the study will closely evaluate ketamine-related behavioral side effects and assess Ketamir-2’s distinct pharmacological profile. The decision to conduct the study in Israel was made to accelerate timelines and optimize costs, allowing Mira to efficiently allocate resources and extend its operational runway. The Company expects Phase 1 to conclude by Q4 2025, paving the way for a Phase 2a study in neuropathic pain patients to be initiated by the end of the year.