on MIRA Pharmaceuticals (NASDAQ:MIRA)
MIRA Pharmaceuticals Pushes Forward with Ketamir-2 Development, Targeting Early Clinical Efficacy in 2025
MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) has announced advances in the development of its novel oral ketamine analog, Ketamir-2. The company aims to demonstrate clinical efficacy as early as 2025 through strategic Phase I/II study designs.
In collaboration with Formulex, MIRA is working on drug product development, focusing on optimizing oral bioavailability of Ketamir-2 capsules. The Investigational New Drug (IND) filing with the FDA is on schedule for December 2024.
Preclinical studies in animal models of Diabetic Neuropathy and Cancer-Induced Neuropathy are ongoing, with results expected by the end of 2024. The Phase I clinical trial design has been finalized and is set to begin in early Q1 2025, assessing safety, tolerability, and pharmacokinetics.
MIRA is exploring additional indications in mental health, including major depressive disorder and PTSD. These initiatives aim to provide early and robust clinical data, positioning Ketamir-2 as a potential treatment for neuropathic pain and other conditions.
R. E.
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