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MIRA Pharmaceuticals Reports Positive Unblinded Phase 1 Data for Ketamir-2

MIRA
  • MIRA Pharmaceuticals announced positive unblinded results from the completed Phase 1 trial of Ketamir-2, a selective oral NMDA receptor modulator.
  • The randomized, double-blind, placebo-controlled study enrolled 57 healthy volunteers across single & multiple ascending dose cohorts with no withdrawals.
  • No serious adverse events or dose-limiting toxicities were reported, & adverse events were predominantly mild.
  • Pharmacokinetic analysis showed rapid oral absorption, dose-proportional Cmax, & consistent systemic exposure between Day 1 & Day 5.
  • The half-life of Ketamir-2 ranged from 2.5 to 7 hours, while its active metabolite nor-Ketamir-2 had a half-life of 7 to 9 hours.
  • The pharmacokinetic profile supports potential once-daily administration, subject to further clinical evaluation.
  • MIRA plans to submit a Phase 2a protocol to the FDA under its active Investigational New Drug application.
  • The Phase 2a study will evaluate Ketamir-2 in patients with moderate to severe chemotherapy-induced peripheral neuropathy (CIPN).
  • CIPN is a debilitating condition with no currently FDA-approved therapies, & the global market is projected to reach $1.7 billion by 2035.
  • Preclinical data demonstrated Ketamir-2's superior efficacy compared to ketamine, pregabalin, & gabapentin in neuropathic pain models.
  • The U.S. Drug Enforcement Administration determined that Ketamir-2 is not classified as a controlled substance.
  • Ketamir-2 is an investigational new molecular entity designed to modulate NMDA receptors with low binding affinity & limited off-target activity.
  • MIRA is advancing preparations for the next development phase following management commentary on the drug's tolerability & therapeutic potential.