Mira Pharmaceuticals enrolls first subjects in Ketamir-2 trial

Mira Pharmaceuticals (MIRA) announced the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in development for the treatment of neuropathic pain. The Phase 1 trial is being conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel. This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers. A total of 56 subjects will be enrolled across both Single Ascending Dose and Multiple Ascending Dose cohorts. This important clinical milestone follows compelling preclinical data, where Ketamir-2 demonstrated superior efficacy compared to FDA-approved neuropathic pain treatments, including pregabalin and gabapentin. It also showed a strong safety profile and oral bioavailability, without the dissociative or psychedelic effects commonly associated with ketamine. Additionally, Ketamir-2 is not a substrate for P-glycoprotein, which supports its ability to efficiently cross the blood-brain barrier-a critical factor in treating central nervous system disorders.