newsfilter
← Latest News
ACCESS Newswire·

MIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a Study

MIRA
  • MIRA Pharmaceuticals has initiated dosing in the final cohort of its Phase 1 multiple ascending dose trial for Ketamir-2, a lead oral NMDA receptor antagonist.
  • To date, 50 healthy volunteers have been dosed, with 6 subjects remaining in the final cohort before the program is expected to conclude by the end of Q1 2026.
  • The Phase 1 study has shown no serious adverse events, supporting the advancement of Ketamir-2 toward a Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy (CIPN).
  • MIRA plans to submit the Phase 2a protocol to the FDA following Phase 1 completion, with initiation anticipated in Q2 2026, subject to regulatory feedback.
  • The company intends to pursue FDA Fast Track designation for Ketamir-2 due to the significant unmet medical need & lack of approved CIPN therapies.
  • MIRA will attend the BIO Partnering Summit on March 2-3, 2026, in Miami to discuss strategic partnerships, collaborations, or mergers.
  • The company will present Phase 1 Ketamir-2 data at the AACR Annual Meeting from April 17-22, 2026, in San Diego.
  • Two preclinical programs, SKNY-1 for weight loss & nicotine addiction, and MIRA-55 for inflammatory pain, are undergoing CMC optimization with goals to reach IND-enabling status by year-end 2026.
  • Ketamir-2 is a non-controlled substance designed as an oral therapy to avoid the psychoactive effects & limitations associated with ketamine.
  • MIRA's pipeline includes SKNY-1, which aims to avoid CNS adverse effects & muscle loss seen with prior CB1 antagonists or injectable GLP-1 therapies.