MIAMI, FL - MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) has reported that its novel oral ketamine analog, Ketamir-2, demonstrated superior pain relief in preclinical studies compared to existing FDA-approved treatments for neuropathic pain. The company's latest findings indicate that Ketamir-2, a non-opioid pain reliever, could offer an effective alternative without the habit-forming risks and side effects associated with current medications.
Key Study Findings:
In a nerve ligation-induced neuropathy model using female rats, Ketamir-2 provided significant pain relief by the 15th day of treatment. By the 22nd day, the results showed up to 112% more effectiveness than Pregabalin and 70% greater relief than Gabapentin at higher doses. This efficacy was consistent with previous studies in male rats, positioning Ketamir-2 as a promising candidate for oral administration.
Limitations of Current Treatments:
Neuropathic pain, often resulting from conditions like diabetes and chemotherapy-induced nerve damage, has a growing demand for better management solutions. Despite the widespread use of Gabapentin and Pregabalin, these drugs are associated with side effects such as drowsiness, dizziness, and potential for misuse or dependence.
Ketamir-2's Advantages:
MIRA Pharmaceuticals highlights several advantages of Ketamir-2, including its non-habit-forming nature and potential to provide superior pain relief with fewer cognitive side effects. The company is also exploring Ketamir-2's application for post-traumatic stress disorder (PTSD) and is seeking government grants to support its development for various neuropsychiatric conditions.
Next Steps for MIRA:
The company plans to submit an Investigational New Drug (IND) application for Ketamir-2 by the end of this year, with Phase 1 clinical trials expected to begin in the first quarter of 2025. Phase 2 trials are slated for the last quarter of 2025, with hopes to observe the first signs of human efficacy by year-end.
MIRA is also working on scientific publications to disseminate its findings and is conducting additional preclinical studies for chemotherapy-induced and diabetic neuropathy. Success in these studies could lead to FDA breakthrough designation, potentially expediting the regulatory approval process.
Based on a press release statement, MIRA Pharmaceuticals is committed to advancing Ketamir-2 through the development process, aiming to provide an innovative treatment option for patients suffering from neuropathic pain and other conditions.
In other recent news, MIRA Pharmaceuticals has made significant strides in its drug development programs, particularly with Ketamir-2 and MIRA-55. The company's oral ketamine analog, Ketamir-2, has shown promising preclinical efficacy against neuropathic pain, outperforming currently approved treatments. MIRA Pharmaceuticals plans to file an Investigational New Drug (IND) application by the end of 2024 and initiate Phase I clinical trials in 2025.
In addition, the company is considering government funding to support potential PTSD trials, indicating a broadening of their research scope. Analyst firm Ascendiant Capital has initiated coverage on MIRA Pharmaceuticals with a 'Buy' rating, acknowledging the company's innovative approach in developing neuroscience programs.
MIRA Pharmaceuticals' Chief Financial Officer, Michelle Yanez, has agreed to a reduced annual base salary, demonstrating her continued commitment to the company. The company has also successfully regained compliance with the Nasdaq's minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market. These are the recent developments in MIRA Pharmaceuticals.
InvestingPro Insights
As MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) advances its promising Ketamir-2 treatment, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at a modest $16.26 million, reflecting its early-stage status in drug development.
InvestingPro Tips highlight that MIRA holds more cash than debt on its balance sheet, which is crucial for a pharmaceutical company in the research and development phase. This financial cushion could provide the necessary runway for Ketamir-2's clinical trials and potential commercialization.
The stock has shown strong momentum recently, with a 59.7% return over the last three months. This surge might reflect investor optimism about Ketamir-2's preclinical results and the company's plans for IND submission and clinical trials.
However, it's important to note that MIRA is not currently profitable, with a negative operating income of $9.72 million in the last twelve months. This is not unusual for biotech companies in the development stage, but it underscores the importance of successful clinical trials and regulatory approvals for MIRA's future.
Investors should be aware that MIRA's stock trades with high price volatility, which is typical for small-cap biotech firms with binary events like clinical trial results on the horizon. The company's Price to Book ratio of 7.33 suggests that the market is pricing in significant growth expectations, likely based on the potential of Ketamir-2.
For those interested in a deeper dive into MIRA's financials and prospects, InvestingPro offers 10 additional tips, providing a more comprehensive analysis of the company's investment potential.
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