MIRA says Ketamir-2 outperforms FDA-approved neuropathic pain treatments

MIRA Pharmaceuticals (MIRA) announced that its novel oral ketamine analog, Ketamir-2, has shown greater pain relief compared to FDA-approved treatments Gabapentin and Pregabalin. Ketamir-2, a non-opioid, offers tremendous promise for patients seeking better solutions for neuropathic pain without the habit-forming risks or debilitating side effects associated with existing medications. The latest preclinical study, conducted using a nerve ligation-induced neuropathy model in female rats, demonstrated that low doses of oral Ketamir-2 provided significant pain relief by Day 15. By Day 22, Ketamir-2 achieved up to 112% more effective results than Pregabalin and 70% greater relief than Gabapentin at higher doses. These findings build on prior studies in male rats, where Ketamir-2 fully reversed neuropathic pain, while oral ketamine showed no effect. This consistent efficacy across different models further highlights Ketamir-2’s potential to deliver superior, effective relief through the oral route, positioning it as a promising alternative to current treatments. Ketamir-2 offers several key advantages over current treatments: Non-Habit Forming: Unlike Pregabalin, Ketamir-2 carries no known risk of dependence, making it safer for long-term use. Superior Pain Relief: The preclinical data shows that Ketamir-2 offers better efficacy than Pregabalin and better efficacy than Gabapentin. Fewer Cognitive Side Effects: With the potential to avoid sedation and cognitive impairment, Ketamir-2 offers an improved quality of life compared to currently available treatments. MIRA is actively preparing to launch preclinical trials for post-traumatic stress disorder, recognizing the urgent need for non-addictive treatments for PTSD. The growing mental health crisis highlights the need for effective alternatives to existing PTSD medications, and Ketamir-2 has the potential to fill that gap. The company is also actively pursuing government grants for PTSD and other indications, capitalizing on the increased public focus and funding initiatives aimed at mental health treatment. These grants could help accelerate the development and delivery of Ketamir-2 to patients suffering from PTSD, depression, and other neuropsychiatric conditions. MIRA is on track to submit an Investigational New Drug application for Ketamir-2 by the end of this year and is currently preparing for Phase 1 clinical trials scheduled to begin in the first quarter of 2025. The company aims to start Phase 2 trials in the last quarter of 2025, allowing for the first signs of human efficacy by the end of that year. As part of these preparations, MIRA is pursuing scientific publications to share progress and insights with the broader medical community. Ongoing preclinical studies are evaluating Ketamir-2’s impact on chemotherapy-induced neuropathy, a condition that, if proven effective, could qualify the drug for FDA breakthrough designation, potentially shortening the regulatory timeline. The company is also conducting further studies for diabetic neuropathy, expanding the therapeutic potential of Ketamir-2.