MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) released new preclinical study results today for Ketamir-2, an oral ketamine analog, indicating that it may offer therapeutic benefits without the psychotic symptoms commonly associated with traditional ketamine. Unlike its traditional counterpart, Ketamir-2 did not induce hyper-locomotion in animal models, a behavior often linked to schizophrenia.
The company, which specializes in neurologic and neuropsychiatric treatments, is preparing to submit an Investigational New Drug Application to the U.S. Food and Drug Administration (FDA) for Ketamir-2 by the end of 2024. This submission will be a significant step toward initiating clinical trials.
MIRA's research, conducted in partnership with Biotrial, focused on spontaneous locomotor activity in mice. Traditional ketamine has been known to cause increased dopamine release leading to hyperactive and psychotic symptoms similar to those observed in schizophrenia patients. Ketamir-2, however, did not produce these effects in the study, suggesting a potentially safer profile for human use.
The findings may have implications for the treatment of mental health disorders and pain management, offering a potentially more patient-friendly option. MIRA's CEO, Erez Aminov, expressed the company's commitment to advancing mental health treatment by providing a safer and more effective alternative to traditional ketamine.
Further studies are underway to support the safety and efficacy of Ketamir-2, expanding its potential application to conditions such as cancer pain and PTSD. MIRA's Chief Scientific Advisor, Itzchak Angel, Ph.D., emphasized the value of the data in enhancing the understanding of Ketamir-2's pharmacological profile.
MIRA holds exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico and is also investigating a novel oral pharmaceutical marijuana analog, MIRA-55, for various neuropsychiatric and neurologic disorders.
The information in this article is based on a press release statement. Ketamir-2 and MIRA-55 are currently in the preclinical development stage, and there is no guarantee that they will successfully complete development or receive FDA approval.
In other recent news, MIRA Pharmaceuticals has made significant strides in the development of its investigational drugs, MIRA-55 and Ketamir-2. The U.S. Drug Enforcement Administration (DEA) has cleared MIRA-55, being studied for neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia, from being classified as a controlled substance. This regulatory advantage simplifies research and development processes for the drug.
MIRA Pharmaceuticals is also making advances with Ketamir-2, an oral ketamine analog under evaluation for ultra-rapid antidepressant effects in treatment-resistant depression and other conditions.
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. This potential partnership could validate Ketamir-2's potential and expand its applications.
Furthermore, MIRA Pharmaceuticals announced the progression of preclinical studies on Ketamir-2 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 to the U.S. Food and Drug Administration by the end of the year.
MIRA Pharmaceuticals is also exploring collaborations for studying Ketamir-2’s efficacy in treating cancer pain, which could further expedite the initiation of human clinical trials.
InvestingPro Insights
As MIRA Pharmaceuticals continues to innovate in the realm of neuropsychiatric treatments, its financial health and market performance are critical factors for investors. According to InvestingPro data, MIRA's market capitalization stands at a modest $10.6 million, reflecting the company's current standing in the competitive pharmaceutical industry.
Investors might be cautious, as the company's P/E ratio is negative, with the latest adjusted P/E ratio for the last twelve months as of Q1 2024 at -0.86. This suggests that MIRA is not currently profitable, a common scenario for biotech companies in the drug development stage. Moreover, the company's stock has experienced significant volatility, with a one-year price total return as of mid-2024 showing a steep decline of -90.34%.
Despite these challenges, MIRA has a couple of financial strengths highlighted by InvestingPro Tips. The company holds more cash than debt on its balance sheet, which could provide flexibility and resilience in funding ongoing research and development. Furthermore, MIRA's liquid assets exceed its short-term obligations, indicating the company's ability to meet its immediate financial commitments.
For investors interested in a deeper dive into MIRA's financials and future prospects, InvestingPro offers a wealth of additional tips. There are currently 7 more InvestingPro Tips available, which could provide valuable insights into MIRA's potential as an investment. For access to these tips, consider subscribing to InvestingPro, and don't forget to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
The journey of MIRA Pharmaceuticals is one to watch, as the success of Ketamir-2 could significantly impact the company's financial trajectory and offer substantial rewards to early investors.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.