MIRA Pharmaceuticals reports key preclinical findings By Investing.com

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a Florida-based pharmaceutical company specializing in pharmaceutical preparations, has announced promising preclinical testing data for its investigational compound, Ketamir-2.

The company, formerly known as Mira1a Therapeutics, Inc., shared the results on Friday, indicating potential advancements in the treatment of neurological and neuropsychiatric disorders, including depression, treatment-resistant depression (TRD), and post-traumatic stress disorder (PTSD).

The data suggests that Ketamir-2 may offer better brain penetration and reduced drug resistance compared to traditional ketamine, due to its ability to avoid interaction with P-glycoprotein (P-gp), a protein that often expels drugs from brain cells. This could lead to more effective oral absorption and enhanced delivery across the blood-brain barrier.

Ketamir-2 is reported to have an estimated oral bioavailability of 80%, a significant improvement over traditional ketamine’s bioavailability, which is under 30%. Preclinical safety profiles indicate that high doses of oral Ketamir-2 are safe and do not induce hyper-locomotion, a common side effect associated with ketamine. Moreover, Ketamir-2 does not interact with the mu-opioid receptor, potentially reducing the risk of opioid-related side effects and dependency.

MIRA Pharmaceuticals is planning to submit an Investigational New Drug application to the U.S. Food and Drug Administration by the end of the year, which would enable human trials to commence if approved.

The company is also conducting ongoing preclinical studies to explore Ketamir-2’s efficacy in treating chemotherapy-induced depression and cancer-related neuropathic pain. Furthermore, due to its unique chemical profile, MIRA Pharmaceuticals is considering pursuing orphan drug designations for conditions such as depression induced by multiple sclerosis and Huntington’s disease.

The announcement includes forward-looking statements, which are subject to risks and uncertainties and should not be seen as guarantees of future performance. The company cautions readers that actual results may differ materially from those projected.

This news is based on a press release statement and constitutes the most recent information available regarding MIRA Pharmaceuticals’ research and development efforts concerning Ketamir-2.

In other recent news, Mira Pharmaceuticals has been navigating through significant developments. The company is facing the risk of Nasdaq delisting due to its stock price remaining below the required threshold.

Still, Mira Pharmaceuticals has been granted a 180-day period to regain compliance. The company is also actively pursuing strategies to tackle this issue, including the initiation of human clinical trials for its novel ketamine-analog compound, Ketamir-2, in early 2025, pending FDA approval.

The company’s CFO, Michelle Yanez, agreed to a reduced annual base salary to accommodate her responsibilities at other companies, while still maintaining her role at Mira Pharmaceuticals. The company’s drug development efforts have also been progressing, with the U.S. Drug Enforcement Administration recently clearing MIRA-55 for further development. This drug is being researched for neuropathic pain, anxiety, and early-stage dementia treatment.

Mira Pharmaceuticals is also advancing its preclinical studies on Ketamir-2, an oral ketamine analog being evaluated for severe post-traumatic stress disorder, depression, and neuropathic pain.

Furthermore, the company is in advanced discussions with Memorial Sloan Kettering Cancer Center to initiate a preclinical study on Ketamir-2 for cancer pain and depression treatment. These are recent developments, and it’s important to note that both MIRA-55 and Ketamir-2 are still in early-stage pre-clinical development and have not yet received FDA approval for marketing.

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