regulatory
confidence high
sentiment positive
materiality 0.60
MIRA submits Phase 2a protocol to FDA for Ketamir-2 in CIPN
MIRA PHARMACEUTICALS, INC.
- Phase 2a protocol (Mira-002) for oral NMDA receptor modulator Ketamir-2 in chemotherapy-induced peripheral neuropathy.
- Randomized, double-blind, placebo-controlled, three-period crossover trial with 300 mg and 600 mg doses.
- No FDA-approved therapies exist for CIPN; study targets 30–40% of chemo patients affected.
- Phase 1 showed clean safety: no serious AEs or dose-limiting toxicities in 56 volunteers.
- Trial to run at a leading U.S. cancer center; FDA acknowledged receipt of submission.