Mira Pharmaceuticals advances Ketamir-2 development

MIRA Pharmaceuticals announced progress in the clinical development planning for its novel oral ketamine analog. As part of its strategic development plan, MIRA is prioritizing the early demonstration of clinical efficacy, potentially as early as 2025, through innovative Phase I/II study designs. MIRA has initiated drug product development of its novel oral ketamine analog in collaboration with Formulex, a leader in nano-technology-based drug delivery and formulation. This partnership focuses on spray-dry based granulation of Ketamir-2 in capsules for clinical studies, optimizing the formulation for improved oral bioavailability and patient convenience. The company is on track for its Investigational New Drug filing for its drug candidate Ketamir-2 with the U.S. Food and Drug Administration in December 2024. MIRA continues to progress with all required Good Laboratory Practice toxicological studies, with data assembly and file preparations well underway. MIRA is committed to detecting an efficacy signal in humans as early as 2025. Through strategic Phase I/II study designs, the company aims to demonstrate the clinical activity in treating neuropathic pain and potentially other neurologic conditions. This approach emphasizes MIRA’s dedication to accelerating the path to clinical efficacy, providing early and robust data that can drive faster decision-making and potentially expedite patient access. MIRA is also conducting ongoing preclinical studies in animal models of Diabetic Neuropathy and Cancer-Induced Neuropathy, with efficacy results expected in late 2024. These studies are critical in refining MIRA’s approach and could help identify more targeted indications within specific patient populations. MIRA has completed the design of its Phase I clinical trial, set to begin in early Q1 2025. This trial will assess safety, tolerability, and pharmacokinetics in humans, laying the groundwork for subsequent efficacy studies. MIRA is also collaborating with leading international academic research institutions to further refine and enhance its clinical development strategy. To bolster its clinical and regulatory approach, MIRA has appointed an experienced consultant who brings extensive expertise from academia and regulatory bodies, including the FDA. In addition to the planned Phase I clinical trial in Q1 2025, MIRA is exploring additional indications in the mental health space, including Major Depressive Disorder with Suicidal Ideation, Treatment-Resistant Depression, and Post-Traumatic Stress Disorder. MIRA aims to broaden the therapeutic applications of its platform to address these unmet needs, with the potential to initiate a depression IND as early as next year.