MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a pre-clinical-stage pharmaceutical company, has reported that its drug candidate Ketamir-2 demonstrated 60% greater efficacy compared to the FDA-approved neuropathic pain treatment gabapentin. This finding comes from a preclinical study aimed at reducing chemotherapy-induced pain.
The study used a paclitaxel (PTX) model to induce neuropathic pain in mice, a side effect commonly associated with chemotherapy drugs. The results indicated that at a dose of 300 mg/kg, Ketamir-2 significantly reduced pain sensitivity in mice, a promising development in the quest for more effective pain management therapies.
These findings will be presented at the Pain Therapeutics Summit in Boston today and tomorrow, where MIRA hopes to engage with key opinion leaders and the broader medical community regarding Ketamir-2's potential.
The positive outcomes from the preclinical study suggest that Ketamir-2 could be on track to receive FDA breakthrough therapy designation, fast track, and/or priority review. This would be particularly beneficial for patients with rare forms of cancer-related neuropathic pain, such as those associated with Multiple Myeloma, who currently have limited treatment options.
MIRA is also exploring Ketamir-2 for other conditions, including diabetic neuropathy and post-traumatic stress disorder (PTSD), and is preparing to submit an Investigational New Drug (IND) application by the end of 2024. The company is considering conducting multiple Phase II trials in parallel to expedite the development process.
Ketamir-2, as a non-opioid analgesic, may offer a safer alternative for long-term pain management without the risks of dependency and other side effects associated with current treatments like gabapentin and pregabalin.
Erez Aminov, Chairman and CEO of MIRA, emphasized the exceptional efficacy of Ketamir-2 in preclinical models and its potential to transform neuropathic pain management. Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, also highlighted the significant progress in pain management that these results represent.
MIRA Pharmaceuticals holds exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico and is investigating the compound's efficacy for various neurologic and neuropsychiatric disorders. The company's other drug candidate, MIRA-55, is being studied for anxiety and cognitive decline related to early-stage dementia.
The information reported is based on a press release statement from MIRA Pharmaceuticals.
In other recent news, Mira Pharmaceuticals has reported significant preclinical success with its novel oral ketamine analog, Ketamir-2, demonstrating superior efficacy compared to existing FDA-approved treatments for neuropathic pain. The company is preparing to submit an Investigational New Drug (IND) application for Ketamir-2 by the end of 2024, with Phase 1 clinical trials expected to begin in 2025. Mira Pharmaceuticals is also examining Ketamir-2's potential application for post-traumatic stress disorder (PTSD).
In addition to these developments, Ascendiant Capital has initiated coverage on Mira Pharmaceuticals with a 'Buy' rating. Mira Pharmaceuticals' Chief Financial Officer, Michelle Yanez, has agreed to a reduced annual base salary, indicating her ongoing 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.
Mira Pharmaceuticals is also in advanced discussions with Memorial Sloan Kettering Cancer Center for a preclinical study on Ketamir-2 for cancer pain and depression treatment. These are the recent developments in Mira Pharmaceuticals.
InvestingPro Insights
MIRA Pharmaceuticals' recent breakthrough with Ketamir-2 has caught the attention of investors, reflected in the company's significant 22.86% return over the last week. This surge aligns with the positive preclinical results announced for their neuropathic pain treatment candidate.
Despite the promising developments, InvestingPro data reveals that MIRA is not currently profitable, with an adjusted operating income of -$9.72 million over the last twelve months as of Q2 2023. This is consistent with the company's pre-clinical stage status, as significant R&D investments are typical at this phase.
InvestingPro Tips highlight that MIRA holds more cash than debt on its balance sheet, which could be crucial for funding further research and clinical trials for Ketamir-2 and other pipeline candidates. Additionally, the company's liquid assets exceed short-term obligations, potentially providing financial flexibility as it moves towards IND submission by the end of 2024.
Investors should note that while MIRA's stock has seen a large price uptick over the last six months (50.03% total return), it's trading at a high Price / Book multiple of 9.46. This valuation may reflect market optimism about the company's potential, particularly in light of the recent Ketamir-2 results.
For those interested in a deeper analysis, InvestingPro offers 10 additional tips for MIRA, providing a more comprehensive view of the company's financial health and market position.
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