MIRA Pharmaceuticals’ Ketamir-2 Outperforms FDA-Approved Gabapentin by 60% in Reducing Chemotherapy-Induced Pain

Shares of MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) rose 14% following the announcement of new preclinical data showing that Ketamir-2, an innovative oral ketamine analog, demonstrated 60% greater efficacy than gabapentin, the current FDA-approved standard, in reducing chemotherapy-induced neuropathic pain. These findings will be presented at the Pain Therapeutics Summit in Boston.

Key Highlights:

• In a preclinical model, Ketamir-2 achieved near-complete normalization of pain sensitivity in mice with chemotherapy-induced neuropathy, significantly outperforming gabapentin.
• Positive results position Ketamir-2 as a candidate for FDA’s breakthrough therapy, fast track, or priority review designations, potentially accelerating its pathway to market.
• MIRA plans to submit an Investigational New Drug (IND) application by the end of 2024, with Phase I clinical trials expected to begin in early 2025. Parallel Phase II trials targeting multiple neuropathic pain conditions are also under consideration.
• Ketamir-2 is under evaluation for other indications, including diabetic neuropathy and post-traumatic stress disorder (PTSD), with preclinical studies underway.

The Pain Therapeutics Summit takes place in Boston on October 28-29, 2024