MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), a pre-clinical-stage pharmaceutical company, announced the advancement of preclinical studies on Ketamir-2, an oral ketamine analog, for the treatment of severe post-traumatic stress disorder (PTSD), depression, and neuropathic pain.
The company 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, which would permit human clinical trials if approved.
MIRA’s ongoing studies include a collaboration with Pharmaseed Ltd to evaluate Ketamir-2's efficacy in a rat model of severe PTSD, aiming to support future clinical applications. In parallel, a study with Biotrial, Inc. is assessing the acute effects of Ketamir-2 on locomotor activity in mice, providing data on the drug's pharmacodynamics and potential side-effect profile.
Moreover, MIRA is conducting 7-day toxicology studies in rats and dogs with Frontage Laboratories, which are essential for ensuring the safety and efficacy of Ketamir-2 before human trials. The company has also made advancements in the drug's manufacturing process, optimizing synthesis and reducing production costs.
Ketamir-2 targets NMDA receptors in the brain, which are crucial for synaptic plasticity and cognitive function. This mechanism of action may offer more effective and faster relief from PTSD symptoms compared to current treatments. MIRA is also exploring collaborations for studying Ketamir-2’s efficacy in treating cancer pain, which could further expedite the IND submission and initiation of human clinical trials.
Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals, expressed optimism about the potential of Ketamir-2 to address critical public health issues related to mental health disorders and pain. Dr. Itzchak Angel, Chief Scientific Advisor, highlighted the drug's high oral bioavailability and lack of mu opioid interaction as factors that could make Ketamir-2 a safer and more effective option for oral administration.
The information in this article is based on a press release statement from MIRA Pharmaceuticals. Ketamir-2 and another of the company's products, MIRA-55, are still in early-stage pre-clinical development and have not yet received FDA approval for marketing.
InvestingPro Insights
As MIRA Pharmaceuticals progresses in its pre-clinical studies for Ketamir-2, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, MIRA Pharmaceuticals holds a market capitalization of $9.68 million, reflecting the size of the company in the competitive pharmaceutical sector.
Despite the potential of Ketamir-2, the company's P/E ratio stands at -1.09, with an adjusted P/E ratio for the last twelve months as of Q1 2024 at -0.78, indicating that the company is not currently profitable.
The stock price has experienced significant volatility, with a 1-week price total return of -8.66% and a 3-month price total return of -38.79%, underscoring the high-risk nature of investing in pre-clinical stage biotech companies. Moreover, MIRA's stock is trading near its 52-week low, with the price at just 8.21% of the 52-week high.
InvestingPro Tips suggest that MIRA's stock is currently in oversold territory based on the Relative Strength Index (RSI), which could indicate a potential rebound opportunity for investors. Furthermore, the company's liquid assets exceed its short-term obligations, providing some financial stability as it continues its drug development endeavors.
For investors looking for more in-depth analysis, InvestingPro offers additional tips on MIRA Pharmaceuticals, which can be accessed at https://www.investing.com/pro/MIRA. For those interested in a subscription, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
With the next earnings date set for May 29, 2024, stakeholders will be anticipating updates on MIRA's financial position and progress with Ketamir-2. The company's journey towards an IND submission is a critical step in the development process, and the investment community will be watching closely to see how these advancements impact the company's valuation and stock performance.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.