MIRA Pharmaceuticals Confirms Ketamir-2 Safety, IND Submission Set For Year-End

MIRA Pharmaceuticals, Inc., a preclinical-stage pharmaceutical company, has completed its GLP preclinical safety studies for Ketamir-2, an innovative oral ketamine analog. The results showed no safety concerns, marking an important step toward filing its Investigational New Drug (IND) application by the end of 2024.

Erez Aminov, CEO and Chairman of MIRA, said in a statement, “Our commitment to advancing Ketamir-2 into clinical trials as quickly as possible reflects our strategic focus on generating proof-of-concept data that positions MIRA for a potential M&A transaction or strategic partnership. This milestone demonstrates our ability to execute efficiently and reinforces our dedication to delivering innovative, safe, and effective treatments for patients suffering from neuropathic pain.”

Safety plays a crucial role in drug development and approval, with nearly 40% of clinical trial failures linked to safety issues. Even after approval, about 30% of FDA-approved drugs face post-market safety warnings or label updates. MIRA’s preclinical studies have confirmed Ketamir-2’s strong safety profile, reducing risks in the development process. This achievement sets the stage for a smoother regulatory journey and improves the chances of success in clinical trials.

Key Preclinical Findings:

• Cardiovascular Safety (Dogs): No adverse effects at therapeutic doses.

• CNS Safety (Rats): No significant changes at therapeutic doses; mild, temporary effects at higher doses.

• Respiratory Safety (Rats): No respiratory issues observed at any dose.

• 14-Day Toxicology (Dogs): Well-tolerated up to 200 mg/kg daily, with no adverse effects.

• Ames Test: Ketamir-2 was non-mutagenic, reinforcing its safety.

  
  

Following the successful completion of preclinical safety studies, MIRA is on track to file its IND application by late 2024. Phase I trials, beginning in Q1 2025, will focus on evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of Ketamir-2 in healthy volunteers. These trials will include pain assessments to gather early data on its effects on neuropathic pain and psychosis, with results expected by Q2 2025. 

The insights will guide Phase IIa patient trials, set to start in Q4 2025, with proof-of-concept findings anticipated by year-end. The Phase I trial’s innovative design allows early testing of Ketamir-2’s potential to manage pain, ensuring future trials are well-informed. This approach supports a smooth transition to patient-focused studies while optimizing clinical strategies.

Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, also stated, “The robust safety data we’ve generated for Ketamir-2 is nothing short of extraordinary. This is a pivotal moment, not just for MIRA, but for the millions of patients suffering from neuropathic pain who are waiting for a safe, non-addictive, and effective treatment. Ketamir-2 represents a groundbreaking step forward in addressing unmet medical needs, and I am confident that it has the potential to redefine treatment paradigms in this space. By strategically designing our Phase I trial to include a comprehensive pain evaluation, we are maximizing the insights we can gain early, positioning us to move into patient trials with a strong understanding of the drug’s effects in humans.”

Neuropathic pain remains a significant unmet need, with many patients lacking safe and effective treatment options. Ketamir-2’s strong safety profile and non-addictive potential could set a new standard in pain management, reducing clinical risks and encouraging collaboration opportunities. MIRA is well-positioned financially to achieve clinical milestones and is exploring non-dilutive funding options to accelerate Ketamir-2’s development and impact.