MIRA Pharmaceuticals, Inc. has announced significant preclinical findings for Ketamir-2, its novel oral ketamine analog, which is currently being investigated for the treatment of neurological and neuropsychiatric disorders, including depression, treatment-resistant depression (TRD), and post-traumatic stress disorder (PTSD).
The company disclosed today that recent preclinical studies have shown Ketamir-2 to be a selective inhibitor of the NMDA receptor, which plays a crucial role in human brain function.
According to the data, Ketamir-2 interacts specifically at the PCP-binding site of the NMDA complex with significantly lower affinity compared to ketamine. This selectivity could lead to fewer side effects, such as dissociation and hallucinations, which are often associated with ketamine.
Furthermore, Ketamir-2's unique profile suggests it does not interact with opioid receptors, dopamine and serotonin transporters, or various acetylcholine receptors, unlike traditional ketamine.
The company highlighted three potential benefits of Ketamir-2's selective binding: reduced side effects due to targeted NMDA receptor interaction, an improved safety profile with potentially fewer adverse reactions, and enhanced therapeutic effectiveness that could lead to more consistent treatment outcomes for conditions like depression, TRD, and PTSD.
In addition to its pharmacological profile, Ketamir-2 has demonstrated no toxicity at very high doses in recent toxicology studies conducted on rats and dogs, suggesting a good safety margin. The drug also showed pronounced antidepressant and anxiolytic activities at doses significantly lower than those tested for toxicity, indicating a substantial therapeutic window.
These positive developments support the company's goal of submitting an Investigational New Drug Application to the U.S. Food and Drug Administration for Ketamir-2 later this year.
The forward-looking statements in the report are based on expectations of future results and are subject to risks and uncertainties. The company cautions that actual results may differ materially from those anticipated in the forward-looking statements and does not assume any obligation to update them as circumstances change.
This news article is based on information provided in a press release statement from an 8-K filing with the Securities and Exchange Commission.
In other recent news, Mira Pharmaceuticals faces potential delisting from the Nasdaq Capital Market due to a sustained period of its stock price falling below the required threshold.
The company is actively pursuing strategies to regain compliance, including the submission of an Investigational New Drug (IND) application for Ketamir-2 to the U.S. Food and Drug Administration (FDA) by the end of 2024. Moreover, Mira Pharmaceuticals has reported positive preclinical results for its compound MIRA-55, designed for treating anxiety and cognitive decline associated with early-stage dementia.
Meanwhile, the company's CFO, Michelle Yanez, has agreed to a reduced annual base salary to accommodate her responsibilities at Telomir Pharmaceuticals and other companies. Despite this change, she will continue her role at Mira Pharmaceuticals. The company has also announced its first annual shareholder meeting, set for September 2024.
On the drug development front, Mira Pharmaceuticals has made progress with its investigational drugs, MIRA-55 and Ketamir-2. The U.S. Drug Enforcement Administration (DEA) recently cleared MIRA-55 for further development, a crucial step as the drug is being researched for neuropathic pain, anxiety, and early-stage dementia treatment.
The company is also advancing its preclinical studies on Ketamir-2, an oral ketamine analog being evaluated for severe post-traumatic stress disorder (PTSD), depression, and neuropathic pain. 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.
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