Mira Pharmaceuticals Announces Positive Preclinical Study Results For Its Novel Oral ketamine Analog, Ketamir-2, Paving the Way for IND Submission Later This Year

Core Insights - MIRA Pharmaceuticals is preparing to submit an Investigational New Drug Application (IND) for Ketamir-2 to the FDA later this year, aiming to initiate human clinical trials [1][2] - The preclinical trials have shown promising results for Ketamir-2, indicating its efficacy and improved safety profile compared to traditional ketamine, which could provide a new treatment option for patients with depression and treatment-resistant depression (TRD) [2][14] Company Overview - MIRA Pharmaceuticals, Inc. is a pre-clinical-stage pharmaceutical development company focused on treating neurologic and neuropsychiatric disorders, holding exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico [10] - The company is also investigating MIRA-55, a novel oral pharmaceutical marijuana analog, for treating neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia [3] Study Findings - The study conducted by Pharmaseed Ltd. evaluated the anti-depressive and anxiolytic effects of Ketamir-2 compared to traditional ketamine using behavioral tests in male mice [15] - Key findings from the study include: - In the Open Field Test (OFT), mice treated with Ketamir-2 showed significantly greater locomotor activity and reduced anxiety levels [12] - In the Elevated Plus Maze (EPM), treated mice exhibited increased travel distance and time spent in open arms, indicating reduced anxiety [12] - In the Forced Swim Test (FST), Ketamir-2 treatment resulted in reduced swimming distances and immobility times, highlighting its potential antidepressant properties [12] Future Directions - MIRA Pharmaceuticals is optimistic about the potential of Ketamir-2 as a safer and more effective treatment option for depression, with ongoing studies evaluating its efficacy in treating post-traumatic stress syndrome and neuropathic pain [16][13] - The U.S. Drug Enforcement Administration's review concluded that Ketamir-2 is not a controlled substance, which may facilitate its development and approval process [10][8]