Mira Pharmaceuticals reports ‘positive’ results from Ketamir-2 study

MIRA Pharmaceuticals 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. The highly encouraging study results further MIRA’s goal of submitting an Investigational New Drug Application to the U.S. FDA later this year which, if granted, would allow for human clinical trials of Ketamir-2. Key Findings from the Study: 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, Elevated Plus Maze, and Forced Swim Test. Under the experimental conditions of these studies, it was possible to use 10 fold-higher oral doses of Ketamir-2, compared with ketamine, which induced major sedative and other side effects already at low doses. The following findings were observed: Open Field Test: Mice treated with Ketamir-2 showed dose-related, significantly greater locomotor activity, higher travel speed and a trend towards an increased time spent in the center of the arena, indicating reduced anxiety levels. Elevated Plus Maze: In this model of depression, significant increases in travel distance and speed were observed in mice treated with Ketamir-2. Furthermore, Ketamir-2 treated mice spent more time in the open arms of the maze, suggesting reduced anxiety. Forced Swim Test: In this model of depression and anxiety, mice in the Ketamir-2 treated arm demonstrated reduced swimming distances and speed, indicating reduced behavioral despair and anti-depressant effect. In addition, Ketamir-2 treatment resulted in significantly reduced immobility times, highlighting its potential antidepressant properties. 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.