MIRA Pharmaceuticals Moves Closer to Human Trials for Ketamir-2

MIRA Pharmaceuticals (MIRA), a preclinical-stage pharmaceutical company, has announced promising results from safety studies on Ketamir-2, a novel oral ketamine analog. The findings, which reveal no safety concerns, mark a major milestone as the company prepares for Phase 1 human trials in early 2025.

“Advancing Ketamir-2 into clinical trials reflects our dedication to creating a safe, effective treatment for neuropathic pain while also positioning MIRA for potential mergers or strategic partnerships,” said Erez Aminov, CEO and Chairman of MIRA.

The Safety Imperative in Drug Development

Safety remains a crucial factor in drug development, often dictating a compound’s progression through clinical trials. Nearly 40% of clinical-stage drug failures are attributed to safety concerns, highlighting the importance of MIRA’s favorable findings. Furthermore, the absence of safety issues in preclinical studies reduces regulatory and developmental risks, allowing the company to move forward confidently.

Key Preclinical Findings

MIRA’s extensive preclinical evaluations demonstrated Ketamir-2’s strong safety profile across several domains:

• Cardiovascular Safety: No adverse effects observed at therapeutic doses in canine studies.
• CNS Assessment: Minimal and transient changes at high doses in rats, with no significant effects at therapeutic levels.
• Respiratory Safety: No respiratory-related side effects across tested doses in rats.
• Toxicology: Ketamir-2 was well-tolerated in 14-day toxicity studies at up to 200 mg/kg per day in dogs.
• Genetic Safety: Non-mutagenic properties confirmed via the Ames test.

These findings suggest Ketamir-2 could offer a safe foundation for treating neuropathic pain, a condition affecting millions worldwide.

Clinical Pathway

MIRA plans to initiate Phase 1 human trials in Q1 2025, aiming to gather insights into the drug’s safety, tolerability, and effects on pain and psychosis. Results from these trials, expected by Q2 2025, will shape subsequent Phase IIa proof-of-concept studies, set to commence in Q4 2025.

Scientific Confidence and Market Potential

Dr. Itzchak Angel, MIRA’s Chief Scientific Advisor, emphasized the significance of these results:
“This robust safety data gives us the confidence to advance Ketamir-2, which could redefine neuropathic pain treatment by providing a non-addictive, effective solution.”

As MIRA targets a substantial unmet need in pain management, the company is exploring non-dilutive funding options to accelerate its efforts and maximize Ketamir-2’s therapeutic potential.

With a strong safety profile and a clear development roadmap, MIRA is well-positioned to redefine the landscape of neuropathic pain treatment, offering hope to patients seeking safer, more effective alternatives.

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