other material
confidence high
sentiment positive
materiality 0.65
Mira Pharmaceuticals announces positive Phase 1 results for Ketamir-2; plans Phase 2a in CIPN
MIRA PHARMACEUTICALS, INC.
- Phase 1 trial in 57 healthy volunteers; all completed with no withdrawals or serious adverse events.
- Ketamir-2 half-life 2.5–7 hours; active metabolite nor-Ketamir-2 half-life 7–9 hours; supports once-daily dosing.
- DEA classified Ketamir-2 as not a controlled substance, eliminating scheduling barriers.
- Company preparing Phase 2a protocol for chemotherapy-induced peripheral neuropathy (CIPN) for FDA submission.
- Preclinical data showed Ketamir-2 superior efficacy vs. ketamine, pregabalin, and gabapentin in neuropathic pain models.