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MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy

MIRA
  • MIRA Pharmaceuticals submitted a Phase 2a clinical trial protocol to the FDA for Ketamir-2, an oral NMDA receptor modulator, to treat chemotherapy-induced peripheral neuropathy (CIPN).
  • The randomized, double-blind, placebo-controlled Phase 2a study (Protocol Mira-002) will evaluate safety, tolerability, & dose-response efficacy of oral Ketamir-2 at a leading U.S. cancer center.
  • Patients with moderate-to-severe persistent CIPN will receive either 300 mg or 600 mg of Ketamir-2 or a placebo across three sequential seven-day treatment periods separated by two-week washouts.
  • The crossover design allows each participant to serve as their own control, with primary objectives focused on neuropathic pain intensity changes measured by the 11-point Numeric Rating Scale.
  • Secondary objectives include assessing the proportion of patients achieving 30% or 50% pain reductions, changes in functional status via the EORTC QLQ-CIPN20, & CNS pharmacodynamic effects.
  • Eligible patients must have persistent CIPN for at least three months, a baseline pain score of 4 or higher, & clinically stable underlying cancer with no active disease requiring systemic treatment.
  • The Phase 2a submission builds on Phase 1 results (MIRA-001) which enrolled 56 healthy volunteers & showed no serious adverse events or dose-limiting toxicities.
  • Ketamir-2 is an oral, once-daily medication confirmed by the DEA as non-scheduled, designed to avoid the limitations of intravenous ketamine such as dissociative side effects.
  • MIRA holds exclusive worldwide rights to Ketamir-2 with intellectual property secured in 10 major markets including the U.S., EU, China, Japan, Canada, Australia, India, Israel, Mexico, & South Korea.
  • There are currently no FDA-approved therapies specifically for CIPN, & existing off-label treatments often provide incomplete relief or force chemotherapy dose reductions.