MIRA submits Ketamir-2 trial protocol
- MIRA Pharmaceuticals (NASDAQ:MIRA) submitted a Phase 2a protocol for Ketamir-2 in chemotherapy-induced peripheral neuropathy after FDA feedback.
- The company targets site initiation in the first quarter of 2027, pending IRB clearance.
- The study will evaluate 300 mg and 600 mg doses against placebo in a crossover design.
MIRA Pharmaceuticals (NASDAQ:MIRA) submitted a Phase 2a clinical trial protocol for Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) following review and feedback from the U.S. Food and Drug Administration.
The company said the study is designed to evaluate Ketamir-2’s potential effects in patients with CIPN, a condition involving nerve damage associated with certain cancer treatments.
The planned trial will compare 300 mg and 600 mg Ketamir-2 doses against placebo using a crossover design to generate initial efficacy and dose-response data, with site initiation targeted for the first quarter of 2027 pending institutional review board clearance..
MIRA Pharmaceuticals develops investigational therapies targeting neurological and psychiatric conditions, including Ketamir-2, which is being evaluated for potential therapeutic applications.
The company said the Phase 2a study is expected to begin at a leading cancer research institution after IRB review and approval, with the trial intended to provide early clinical data on Ketamir-2 in CIPN.
