other_material
confidence high
sentiment positive
materiality 0.65
MIRA Pharmaceuticals completes Phase 1 SAD for Ketamir-2; no safety issues, advances to MAD
MIRA PHARMACEUTICALS, INC.
- Completed SAD phase with 32 participants across 4 cohorts (50-600 mg); no severe adverse effects observed.
- Advancing to MAD phase with 3 cohorts (150, 300, 600 mg daily for 5 days) in up to 24 participants.
- FDA IND clearance for neuropathic pain already received; U.S. Phase 2a trial planned for Q4 2025.
- Safety monitored via C-SSRS, Bowdle VAS, and KSET scales; no clinically significant safety concerns.
item 8.01