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MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2
Advancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and
About this update from Mira Pharmaceuticals, Inc.
[{"type":"text","content":"Advancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and tolerability findings MIAMI, FLORIDA / ACCESS Newswire / March 4, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) (\"MIRA\" or the \"Company\"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today 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 (SAD) and multiple ascending dose (MAD) 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 (AACR) Annual Meeting.Phase 1 Clinical OverviewThe study was conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel, and was designed to characterize the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2.Study DesignRandomized, double-blind, placebo-controlledSAD: Four dose cohorts (50 mg to 600 mg), 32 participantsMAD: Three cohorts (150 mg, 300 mg, 600 mg daily for five days), 24 participantsStudy Endpoints: Safety, tolerability, pharmacokineticsCentral nervous system safety was prospectively evaluated using validated clinical instruments, including the Columbia-Suicide Severity Rating Scale (C-SSRS), Bowdle Visual Analogue Scale (VAS), and the Ketamine Side Effect Tool (KSET), to assess dissociative, perceptual, or mood-related effects.Targeting a High-Unmet-Need Indication: Chemotherapy-Induced Peripheral Neuropathy (CIPN)MIRA intends to submit the Phase 2a clinical study and supporting documentation to the U.S. Food and Drug Administration under its active IND in the first half of 2026, targeting patients with mo...