MIRA Pharmaceuticals Plunges 10.93% Despite Promising Ketamir-2 Data

On April 17, 2025, MIRA's stock price dropped by 10.93% in pre-market trading.

MIRA Pharmaceuticals recently announced positive results for its oral ketamine analog, Ketamir-2, in a diabetic neuropathy animal model. The study demonstrated significant reduction in neuropathic pain symptoms, with some subjects achieving complete reversal to pre-diabetic baseline sensitivity. This development is particularly encouraging as it suggests that Ketamir-2 could offer a safer and more effective alternative to current treatments for diabetic neuropathy.

Ketamir-2 has shown superior performance compared to FDA-approved medications like pregabalin and gabapentin in preclinical studies. Unlike traditional ketamine, it doesn't cause dissociative effects and offers better blood-brain barrier penetration. The company is currently conducting a Phase I clinical trial at Hadassah Medical Center, with completion expected in Q4 2025. MIRA plans to initiate a Phase IIa trial in diabetic neuropathy patients by year-end, with first human efficacy data expected in H1 2026.

MIRA's strategic positioning with Ketamir-2 appears well-aligned with multiple healthcare trends and market opportunities. The company is targeting diabetic neuropathy - a condition with high prevalence affecting up to 55% of diabetic patients worldwide and representing substantial unmet need given the limitations of current therapies. Their approach addresses three convergent market dynamics: 1) increasing diabetes prevalence driving neuropathy cases, 2) growing demand for non-opioid pain solutions amid the ongoing opioid crisis, and 3) FDA prioritization of neuropathic pain treatments through potential accelerated pathways.

While the positive preclinical results strengthen MIRA's narrative, the most critical milestones remain ahead: Phase I completion in Q4 2025 and Phase IIa efficacy data in 2026. The development of a topical formulation could further expand addressable markets by providing localized treatment with minimized systemic exposure. For a company with a market cap of $14.8 million, successful execution across these programs could represent significant upside potential.