Mira Pharma Reports Positive Preclinical Results for Oral Ketamine Analog Ketamir-2, Eyes IND Submission This Year

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), a preclinical-stage company dedicated to developing treatments for neurological and psychiatric disorders, has announced encouraging preclinical results for its novel oral ketamine analog, Ketamir-2. The findings highlight Ketamir-2's potential efficacy and safety as a treatment for depression and treatment-resistant depression (TRD).

The preclinical studies, conducted by Pharmaseed Ltd., assessed the anti-depressive and anxiolytic properties of Ketamir-2 in male mice using the Open Field Test (OFT), Elevated Plus Maze (EPM), and Forced Swim Test (FST). Notably, Ketamir-2 was administered at doses up to ten times higher than traditional oral ketamine, which resulted in significant sedative side effects at lower doses.

Key Findings from the Preclinical Studies

- Open Field Test (OFT): Mice treated with Ketamir-2 exhibited a remarkable increase in locomotor activity and travel speed. There was also a trend towards more time spent in the center of the arena, suggesting reduced anxiety levels.

- Elevated Plus Maze (EPM): In this test, Ketamir-2-treated mice demonstrated significant increases in travel distance and speed. Additionally, they spent more time in the open arms of the maze, which is indicative of reduced anxiety.

- Forced Swim Test (FST): In this model, mice treated with Ketamir-2 showed decreased swimming distances and speed, reflecting reduced behavioral despair and an anti-depressant effect. The treatment also resulted in a significant reduction in immobility times, underscoring its potential antidepressant properties.

Traditional ketamine was used as a control in these studies but was less effective at the highest feasible oral dose compared to Ketamir-2. This points to Ketamir-2's superior profile when administered orally.

Clinical Implications and Future Directions

The promising results from these studies bolster MIRA's plans to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) later this year. If approved, this would pave the way for human clinical trials of Ketamir-2.

"We are thrilled with the results, which demonstrate Ketamir-2's efficacy and improved safety profile over traditional ketamine," said Erez Aminov, CEO of MIRA Pharmaceuticals. "These findings are a significant milestone as we prepare for an IND submission to the FDA. We hope Ketamir-2 will provide a new, safer treatment option for patients struggling with depression and TRD."

Dr. Itzchak Angel, Chief Scientific Advisor at MIRA Pharmaceuticals, added, "The data from these studies will be invaluable in showcasing Ketamir-2's benefits. Its oral activity, favorable pharmacological profile, and lack of unwanted side effects make it a potentially safer and more effective treatment for depression in a home setting."

About MIRA Pharmaceuticals

MIRA Pharmaceuticals, Inc. is a preclinical-stage pharmaceutical development company with a focus on treatments for neurological and neuropsychiatric disorders. The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2, a novel oral ketamine analog aimed at providing rapid antidepressant effects. Ketamir-2 is designed to be a non-controlled substance under DEA regulations, which could facilitate its use and distribution.

In addition to Ketamir-2, MIRA is also investigating MIRA-55, an oral pharmaceutical marijuana analog, for treating neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia. Like Ketamir-2, MIRA-55 is not considered a controlled substance under DEA rules and could offer a significant advancement in treating various neuropsychiatric and neurologic conditions if approved by the FDA.

Overall, the positive preclinical results for Ketamir-2 mark a significant step forward in developing new, effective treatments for depression and other neuropsychiatric disorders. As MIRA Pharmaceuticals prepares for further studies and potential FDA approval, there is renewed hope for patients seeking better therapeutic options.

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