Filing Analysis
Regulation FD Disclosure
Filed Mar 23, 2026
MEDIUM
MIRA Pharmaceuticals reported positive preclinical data for its drug candidate Mira-55, demonstrating a lack of cannabinoid-related CNS side effects and reduced anxiety-like behavior. The company is leveraging these results to support an upcoming Investigational New Drug (IND) submission for inflammatory pain.
Key Facts
- Preclinical study conducted in collaboration with Pharmaseed evaluated Mira-55 at doses of 10, 30, and 100 mg/kg.
- Mira-55 showed no evidence of sedation, catalepsy, or motor impairment, unlike THC or rimonabant.
- The drug candidate demonstrated a dose-dependent increase in time spent in open arms during Elevated Plus Maze (EPM) testing, suggesting reduced anxiety.
- Previous data indicated Mira-55 provides morphine-comparable analgesic effects without opioid-related risks.
- The company is currently advancing Mira-55 toward an IND submission for inflammatory pain.
Other SEC Filing
Filed Mar 03, 2026
LOW
MIRA Pharmaceuticals announced the completion of Phase 1 dosing for Ketamir-2, its proprietary oral NMDA receptor modulator. The study in 56 healthy volunteers showed no serious adverse events or dissociative effects, clearing the path for a Phase 2a submission in the first half of 2026.
Key Facts
- Completed Phase 1 dosing for Ketamir-2 in 56 healthy adult volunteers at Hadassah Medical Center.
- The study included Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts with doses up to 600 mg.
- No serious adverse events (SAEs), dose-limiting toxicities (DLTs), or dissociative/psychotomimetic effects were reported.
- Company plans to submit Phase 2a clinical study documentation to the FDA in H1 2026.
- The upcoming Phase 2a study will target moderate to severe chemotherapy-induced peripheral neuropathy (CIPN).
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