Mira Pharmaceuticals Begins Final Dosing in Phase 1 Trial of Ketamir-2

Mira Pharmaceuticals Inc. announced the initiation of dosing in the final cohort of its Phase 1 multiple ascending dose (MAD) clinical trial for Ketamir-2, its lead oral NMDA receptor antagonist. To date, 50 healthy volunteers have been dosed, with six subjects remaining in the final cohort. The company expects to complete the Phase 1 clinical program by the end of the first quarter of 2026. The Phase 1 study is a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of single and multiple oral doses of Ketamir-2. Mira Pharmaceuticals also provided updates on its preclinical pipeline. SKNY-1, an orally administered small-molecule program for weight loss and nicotine addiction, and MIRA-55, a program for inflammatory pain, are both undergoing CMC optimization with the aim of advancing each into IND-enabling status by year-end 2026. The company is finalizing its Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy (CIPN) and plans to submit the protocol to the FDA after completing Phase 1. Subject to regulatory feedback, the Phase 2a study is expected to begin in the second quarter of 2026. Mira Pharmaceuticals intends to seek FDA Fast Track designation for Ketamir-2 for CIPN. The company also plans to engage in partnering discussions at the BIO Partnering Investment & Growth Summit in March 2026 and present Phase 1 data at the AACR Annual Meeting in April 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Mira Pharmaceuticals Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001493152-26-004739), on February 02, 2026, and is solely responsible for the information contained therein.