Mira Pharmaceuticals, Inc. announced positive preclinical study results highlighting the potential efficacy and safety profile of Ketamir-2, MIRA's novel oral ketamine analog designed to treat depression and treatment-resistant depression (TRD). The highly encouraging study results further MIRA's goal of submitting an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) later this year which, if granted, would allow for human clinical trials of Ketamir-2. The study, conducted by Pharmaseed Ltd., evaluated the anti-depressive and anxiolytic effects of oral Ketamir-2, in comparison with oral ketamine, using established behavioral tests in male mice. The tests included the Open Field Test (OFT), Elevated Plus Maze (EPM), and forced Swim Test (FST).

Traditional ketamine was used as a positive control in this study. In many of the above parameters, traditional ketamine given orally at the highest dose feasible was inactive, again pointing to the comparative potential benefits of Ketamir-2., which is designed to be delivered orally. Clinical Implications and Future directions: The positive results from this preclinical study underscore Ketamir-2's potential as a superior alternative to traditional ketamine.

Ongoing studies with third-party research organizations Pharmaseed and Biotrial are evaluating Ketamir-2's efficacy in treating post-traumatic stress syndrome and neuropathic pain, as well as conducting further safety studies in comparison to ketamine.