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MIRA Pharmaceuticals Progresses MIRA-55 and SKNY-1 Toward IND-Enabling Studies

  • MIRA Pharmaceuticals announced continued advancement of lead preclinical programs MIRA-55 for chronic inflammatory pain & SKNY-1 for obesity & addiction-related disorders.
  • The Company advanced both candidates through formulation optimization, CMC activities, manufacturing development, & exploratory non-GLP toxicology studies.
  • Exploratory 7-day repeated-dose toxicology studies were completed in Sprague Dawley rats & Beagle dogs to inform future GLP-compliant IND-enabling study designs.
  • Current CMC efforts focus on analytical, formulation, & manufacturing development to support upcoming nonclinical safety studies.
  • MIRA-55 demonstrated direct CB2 receptor-mediated anti-inflammatory activity & outperformed injected morphine in preclinical pain models without THC-like CNS effects.
  • SKNY-1 showed dose-dependent reductions in body weight, lipid normalization, & attenuation of compulsive feeding & nicotine-seeking behaviors in preclinical studies.
  • Both drug candidates were determined by the U.S. DEA to not be classified as controlled substances.
  • MIRA's pipeline also includes Ketamir-2, which completed Phase 1 trials & is advancing toward Phase 2a for chemotherapy-induced peripheral neuropathy.