MIRA Completes Ketamir-2 Phase 1 Dosing in 56 Volunteers with No Serious AEs
MIRA Pharmaceuticals completed dosing in its Phase 1 trial of Ketamir-2, enrolling 56 healthy volunteers across single ascending dose (50–600 mg) and multiple ascending dose (150–600 mg) cohorts with no serious adverse events or dose-limiting toxicities. The company plans a Phase 2a IND submission in H1 2026 targeting the $1.7 billion chemotherapy-induced peripheral neuropathy market.
1. Phase 1 Trial Completion
MIRA Pharmaceuticals has finished dosing in its randomized, double-blind, placebo-controlled Phase 1 study of Ketamir-2 at the Clinical Pharmacology Unit in Jerusalem. The trial enrolled 56 healthy adult volunteers across single ascending dose cohorts (50–600 mg) and multiple ascending dose cohorts (150–600 mg), generating a full safety dataset for regulatory submission.
2. Safety and Tolerability Findings
No serious adverse events or dose-limiting toxicities were reported at any dose level, and central nervous system assessments revealed no clinically significant dissociative or psychotomimetic effects. Final pharmacokinetic and safety analyses are underway ahead of database lock and unblinding.
3. Phase 2a Development Plan
MIRA intends to submit its IND application in the first half of 2026 to initiate a proof-of-concept Phase 2a trial in patients with moderate to severe chemotherapy-induced peripheral neuropathy. The study will incorporate validated neuropathic pain endpoints and robust statistical powering to capture safety and preliminary efficacy in a market projected to reach $1.7 billion by 2035.