Mira Pharmaceuticals presents preclinical data for Ketamir-2

MIRA Pharmaceuticals announced that new preclinical data on its lead development product, Ketamir-2, will be presented at the 18th Annual Pain Therapeutics Summit, taking place on October 28-29, 2024, in Boston, MA. The presentation, entitled “Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment,” will showcase the breakthrough finding that Ketamir-2 achieved a complete reversal of neuropathic pain in preclinical models. Neuropathic pain, caused by nerve damage or dysfunction, remains a major challenge in pain management due to the limited efficacy and significant side effects of current therapies. Ketamir-2 a novel oral Ketamine analog, selectively targets the PCP site of the NMDA receptor, offering enhanced efficacy with fewer side effects compared to ketamine. In preclinical studies using the Chung model of neuropathic pain, Ketamir-2 given orally, demonstrated superior efficacy compared to ketamine, achieving 100% reversal of pain responses, representing a full normalization of the response. These findings underscore Ketamir-2’s potential as a breakthrough therapy for neuropathic pain, providing more consistent pain relief with reduced risk of adverse effects. MIRA is advancing the development of Ketamir-2 through ongoing preclinical studies and is preparing to publish its findings in peer-reviewed journals. The company remains on track to submit an Investigational New Drug application to the U.S. FDA by December 2024, with plans to demonstrate an efficacy signal in humans as early as 2025. To achieve this, MIRA has designed strategic Phase I/II studies aimed at showcasing Ketamir-2’s clinical effectiveness in treating neuropathic pain and potentially other neurological conditions. This approach underscores the company’s commitment to accelerating the pathway to clinical success, delivering early and impactful data that will drive timely decision-making and help expedite patient access to innovative treatments.