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MIRA Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN

MIRA
  • MIRA Pharmaceuticals executed Amendment No. 1 to its exclusive Ketamir-2 license with MIRALOGX LLC to expand licensed territory from the U.S., Canada, & Mexico to worldwide rights.
  • The amended agreement covers an international patent portfolio including filings in the U.S., Europe, China, Japan, Canada, Australia, India, Israel, Mexico, & South Korea.
  • Ketamir-2 is a proprietary oral NMDA receptor modulator advancing toward Phase 2a development for chemotherapy-induced peripheral neuropathy (CIPN).
  • Phase 1 clinical results across 56 healthy volunteers demonstrated favorable safety, tolerability, & pharmacokinetics with no serious adverse events or study discontinuations.
  • Chairman & CEO Erez Aminov stated the worldwide rights strengthen MIRA's ability to pursue global licensing, co-development, or commercialization discussions.
  • The amendment does not materially modify the core economic terms of the original license agreement.
  • MIRA is advancing Phase 2a protocol documentation for submission to the FDA under its active Investigational New Drug (IND) application.
  • Preclinical models showed Ketamir-2 demonstrated improved efficacy compared to ketamine, pregabalin, & gabapentin in neuropathic pain models.
  • The U.S. Drug Enforcement Administration (DEA) determined Ketamir-2 is not classified as a controlled substance.
  • Ketamir-2 remains unapproved by the FDA for any indication as its safety & efficacy have not been established.