MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is set to initiate a Phase I/IIa clinical trial for Ketamir-2, a novel oral ketamine analog, targeting neuropathic pain. The trial, scheduled to begin recruitment in Q1 2025, will be conducted at The Centre for Human Drug Research (CHDR) in Leiden, Netherlands. This randomized, double-blind, placebo-controlled study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of Ketamir-2. Initial Phase I results are expected in H2 2025, with Phase IIa results anticipated in H1 2026.
Innovative Protocol Design
The Phase I/IIa trial employs an innovative design to gather early proof-of-concept data. Phase I involves single ascending dose (SAD) and multiple ascending dose (MAD) cohorts in healthy subjects. CHDR's proprietary PainCart technology, a validated tool for measuring pain response, will be used to assess early signs of efficacy. Psychoactivity assessments will also be conducted separately. Phase IIa, planned for Q4 2025, will focus on diabetic neuropathy patients to validate Phase I findings and generate efficacy data in a patient population with unmet needs.
Preclinical Efficacy and Safety
Ketamir-2 has demonstrated promising preclinical results, outperforming pregabalin and gabapentin in efficacy studies. Notably, no side effects have been observed in preclinical studies to date. This positions Ketamir-2 as a potential breakthrough therapy for pain management, addressing the urgent need for safe, effective, and non-addictive treatments.
Strategic Focus and Financial Position
MIRA Pharmaceuticals believes it has a healthy balance sheet, enabling the company to pursue strategic partnerships and advance Ketamir-2's clinical development. The company is also actively pursuing non-dilutive grant opportunities and preparing scientific journal publications to enhance understanding of Ketamir-2's mechanism of action and potential therapeutic applications.
Expert Commentary
"This innovative protocol is designed to deliver early, robust proof-of-concept data, advancing Ketamir-2's clinical development and positioning us for strategic partnerships or an M&A opportunity," said Erez Aminov, CEO and Chairman of MIRA Pharmaceuticals. Dr. Itzchak Angel, Chief Scientific Advisor at MIRA Pharmaceuticals, added, "The ability to gather early efficacy data in healthy subjects provides an invaluable opportunity to optimize the drug's potential and streamline its progress toward addressing the unmet needs in pain management."
