MIRA Pharmaceuticals Files FDA Protocol for 300mg/600mg Phase 2a CIPN Trial
MIRA•MIRA Pharmaceuticals has submitted an FDA protocol for a Phase 2a randomized, double-blind, placebo-controlled crossover trial evaluating oral Ketamir-2 at 300 mg and 600 mg in patients with moderate-to-severe chemotherapy-induced peripheral neuropathy. The study will enroll participants in three seven-day dosing periods separated by two-week washouts to assess safety, tolerability and pain reduction.
1. FDA Protocol Submission
MIRA Pharmaceuticals has formally submitted a Phase 2a clinical trial protocol for Ketamir-2 to the U.S. FDA, targeting chemotherapy-induced peripheral neuropathy (CIPN). This marks the company’s transition from Phase 1 safety assessments to patient-focused efficacy evaluation in a population with persistent neuropathic pain.
2. Trial Design and Objectives
The study is a randomized, double-blind, placebo-controlled, three-period crossover trial at a major U.S. cancer center. Patients will receive 300 mg, 600 mg or placebo of oral Ketamir-2 across three sequential seven-day periods, each separated by a two-week washout, with primary endpoints of safety, tolerability and change in weekly mean pain scores.
3. Phase 1 Data and Next Steps
In the completed Phase 1 trial, 56 healthy volunteers showed no serious adverse events or dose-limiting toxicities, supporting once-daily dosing at the selected levels. Results from Phase 2a will inform dose-response relationships and pave the way for larger pivotal studies if efficacy and safety targets are met.
