MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), a company specializing in neurologic and neuropsychiatric disorders, today announced encouraging results from a preclinical study of Ketamir-2, an oral ketamine analog. The study suggests that Ketamir-2 could be a more effective and safer alternative to traditional ketamine for treating depression and treatment-resistant depression (TRD).
The preclinical research, conducted by Pharmaseed Ltd., compared the effects of Ketamir-2 to oral ketamine in male mice across behavioral tests designed to measure antidepressant and anxiolytic properties. Notably, Ketamir-2 enabled the use of doses ten times higher than ketamine without inducing the latter's common sedative side effects.
Ketamir-2 showed a significant increase in locomotor activity and travel speed, and a trend towards more time spent in the center of the arena in the Open Field Test (OFT), suggesting reduced anxiety levels. In the Elevated Plus Maze (EPM) and Forced Swim Test (FST), the mice exhibited behaviors indicative of reduced anxiety and depression, such as increased time spent in the open arms of the maze and reduced immobility times.
Erez Aminov, Chairman & CEO of MIRA Pharmaceuticals, expressed optimism about the findings, stating that they represent a significant step towards submitting an Investigational New Drug Application (IND) to the FDA. Dr. Itzchak Angel, Chief Scientific Advisor, highlighted the potential benefits of Ketamir-2, emphasizing its activity via oral administration and lack of unwanted side effects.
MIRA holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2, which is also being evaluated for post-traumatic stress syndrome and neuropathic pain. The Drug Enforcement Administration (DEA) has determined that Ketamir-2 is not a controlled substance under current regulations.
The company 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 by the DEA.
Ketamir-2 and MIRA-55 are still in the early stages of development, and there is no guarantee they will progress through development or receive FDA approval. This news is based on a press release statement from MIRA Pharmaceuticals.
In other recent news, MIRA Pharmaceuticals has seen several key developments. The U.S. Drug Enforcement Administration (DEA) has cleared its investigational drug MIRA-55 from being classified as a controlled substance, a significant step forward for the company. MIRA-55 is currently under study for the treatment of neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia.
In addition, MIRA Pharmaceuticals is in advanced discussions with Memorial Sloan Kettering Cancer Center (MSK) to initiate a preclinical study on Ketamir-2, an oral ketamine analog for cancer pain and depression treatment. This partnership could potentially validate Ketamir-2's potential and mark a pivotal step in MIRA's efforts to expand the compound's applications.
The company also reported progress in preclinical studies on Ketamir-2 for the treatment of severe post-traumatic stress disorder (PTSD), depression, and neuropathic pain. MIRA is working towards submitting an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) by the end of the year.
Furthermore, MIRA announced that its investigational compound Ketamir-2 has shown promise in pre-clinical studies for the treatment of major mental health disorders. Lastly, the company announced a reshuffle of its board, with three members stepping down, aiming to enhance the board's expertise in relevant scientific areas. These are all recent developments in MIRA Pharmaceuticals' ongoing operations.
InvestingPro Insights
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) has recently made headlines with its promising preclinical study results for Ketamir-2, but the company's financial health and stock performance paint a more complex picture. With a market capitalization of just 11.23 million USD, MIRA is a relatively small player in the pharmaceutical industry. The company's stock has experienced significant volatility, as indicated by a 10.66% price drop over the past week and a staggering 89.76% decline over the past year.
An important factor for investors to consider is MIRA's financial strength. According to InvestingPro Tips, the company holds more cash than debt on its balance sheet and its liquid assets exceed short-term obligations, which may provide some financial flexibility as it continues to develop its drug candidates. Still, MIRA is not currently profitable, with a negative P/E ratio of -0.91 for the last twelve months as of Q1 2024, and it does not pay dividends to shareholders.
For those considering an investment in MIRA Pharmaceuticals, it's worth noting that the stock's price is currently at 9.52% of its 52-week high, which could indicate a potential discount if the company's prospects improve. Additionally, the company's next earnings date is set for August 28, 2024, which could provide further insight into its financial trajectory and the progress of its drug development programs.
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