other material
confidence high
sentiment positive
materiality 0.55
MIRA completes Phase 1 dosing of Ketamir-2; no serious AEs; plans Phase 2a in CIPN
MIRA PHARMACEUTICALS, INC.
- Completed Phase 1 study in 56 healthy volunteers; no serious adverse events or dose-limiting toxicities.
- No clinically significant dissociative or psychotomimetic effects typically seen with ketamine observed.
- Plans to submit Phase 2a proof-of-concept study to FDA in H1 2026 for chemotherapy-induced peripheral neuropathy (CIPN).
- CIPN lacks FDA-approved therapies; Ketamir-2 is a selective oral NMDA receptor modulator.