MIRA PHARMACEUTICALS, INC. 8-K

What Happened MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced in an 8-K filed March 3, 2026 that it has completed dosing in its Phase 1 trial of Ketamir-2, a selective oral NMDA receptor modulator, in 56 healthy volunteers. The randomized, double-blind, placebo-controlled study (conducted at Hadassah Medical Center, Jerusalem) included single ascending dose (SAD) cohorts of 50–600 mg and multiple ascending dose (MAD) cohorts of 150 mg, 300 mg, or 600 mg daily for five days. To date, the company reported no serious adverse events, no dose-limiting toxicities, and no clinically significant dissociative or psychotomimetic effects; database lock, unblinding, and final audited PK and safety analyses are underway.

Key Details

• Trial size: 56 healthy adults (SAD: 32 participants across four dose levels; MAD: 24 participants across three dose levels).
• Doses tested: SAD 50–600 mg; MAD 150 mg, 300 mg, 600 mg daily for 5 days.
• Safety: No serious adverse events (SAEs) or dose-limiting toxicities reported; no ketamine-like dissociative/psychotomimetic effects observed.
• Next steps: Company plans to submit Phase 2a study and supporting documentation to FDA under its active IND in H1 2026 and will present Phase 1 data at an upcoming scientific meeting. Planned Phase 2a will target patients with moderate to severe chemotherapy-induced peripheral neuropathy (CIPN).

Why It Matters The clean Phase 1 safety and tolerability readout is a key de‑risking milestone that allows MIRA to advance Ketamir-2 toward a proof-of-concept Phase 2a study. CIPN currently has no FDA‑approved treatments specifically indicated for it, so successful clinical development could address a significant unmet medical need. Investors should note that these results are safety/PK-focused — efficacy in patients has not yet been reported; upcoming catalysts include final audited Phase 1 data, the IND/Phase 2a submission in H1 2026, and initiation/results of the Phase 2a study.