MIRA Pharmaceuticals Reports Safe Tolerability and Favorable PK in 57-Volunteer Ketamir-2 Phase 1 Trial
MIRA Pharmaceuticals reported positive data from its Phase 1 trial of Ketamir-2 in 57 volunteers, with no serious adverse events and lower adverse-event rate than placebo. Pharmacokinetics showed rapid oral absorption, dose-proportional Cmax and half-lives of 2.5–7 hours and 7–9 hours, supporting once-daily dosing and Phase 2a development in chemotherapy-induced peripheral neuropathy.
1. Phase 1 Trial Design
MIRA conducted a randomized, double-blind, placebo-controlled Phase 1 study of Ketamir-2 in 57 volunteers across seven single and multiple ascending dose cohorts, with all subjects completing the trial and fitting for discharge after final administration.
2. Safety and Tolerability
No serious adverse events or dose-limiting toxicities were reported. Mild adverse events occurred more frequently in the placebo group than in Ketamir-2 cohorts, indicating a favorable safety and tolerability profile.
3. Pharmacokinetic Profile
Pharmacokinetic analysis showed rapid oral absorption with dose-proportional Cmax across evaluated doses. Ketamir-2 half-life ranged from 2.5 to 7 hours and its active metabolite from 7 to 9 hours, supporting potential once-daily administration.
4. Next Steps and Market Outlook
MIRA plans to submit its Phase 2a protocol for chemotherapy-induced peripheral neuropathy under its active IND, targeting a market projected to reach $1.7 billion by 2035. The proof-of-concept study will evaluate Ketamir-2 in patients with moderate to severe CIPN.