$MIRA·8-K

MIRA PHARMACEUTICALS, INC. · Mar 23, 9:00 AM ET

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MIRA PHARMACEUTICALS, INC. 8-K

Research Summary

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MIRA Pharmaceuticals Reports Mira-55 Preclinical Safety, Moves Toward IND

What Happened

  • On March 23, 2026, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) reported new preclinical CNS and behavioral data on its investigational compound Mira-55 from studies run with Pharmaseed. Oral doses of 10, 30, and 100 mg/kg were tested and compared to Δ9-THC and the CB1 antagonist rimonabant across hypothermia, catalepsy, Elevated Plus Maze (EPM), and Open Field (OF) assays.
  • The company reported no cannabinoid-like psychogenic effects, no sedation, catalepsy, or motor impairment at any tested dose. Mira-55 showed a dose-dependent increase in time spent in open arms in the EPM (consistent with reduced anxiety-like behavior) and performance in OF testing comparable to vehicle controls. Rimonabant produced anxiety-like effects in the model, supporting assay sensitivity.
  • These results add to prior preclinical findings that Mira-55 produced morphine-comparable analgesia in a validated inflammatory pain model and bolster the company’s stated plan to advance Mira-55 toward an Investigational New Drug (IND) submission for inflammatory pain.

Key Details

  • Filing date: March 23, 2026 (Form 8-K).
  • Doses tested: oral Mira-55 at 10, 30, and 100 mg/kg; compared to THC and rimonabant.
  • Assays used: hypothermia, catalepsy, Elevated Plus Maze (EPM), Open Field (OF).
  • Prior result referenced: Mira-55 showed morphine-comparable analgesic effects in an inflammatory pain model; company is conducting additional preclinical studies to support an IND.

Why It Matters

  • For investors, the new data speak to the CNS safety profile of Mira-55 in preclinical models—no THC- or rimonabant-like adverse behavioral effects were observed—reducing a key safety concern for cannabinoid-related drug candidates.
  • Combined with prior analgesia data, these findings support MIRA’s stated path toward an IND for inflammatory pain; the company will need to complete further preclinical work and regulatory filings before human trials can begin.