MIRA Pharmaceuticals, Inc. reported positive results from a 21-day preclinical proof-of-concept study evaluating MIRA-55 in a model of chronic inflammatory pain. The study, conducted by an independent contract research organization using the Complete Freund's Adjuvant (CFA) model, involved 72 male and female rats.
The data indicates that once-daily oral administration of MIRA-55 significantly reduced both mechanical and thermal pain hypersensitivity compared to vehicle-treated animals (p < 0.001). The study found that MIRA-55 achieved pain-relieving effects comparable in magnitude to celecoxib (Celebrex), a widely prescribed anti-inflammatory medication, at higher dose levels.
Key findings from the study include:
- Sustained Efficacy: Pain relief was maintained throughout the three-week study without evidence of tolerance or a decline in effectiveness.
- Reduced Inflammation: MIRA-55 reduced inflammation-associated paw swelling to a similar magnitude as celecoxib.
- Tolerability: The compound was well tolerated, with no adverse clinical signs or deaths reported, and normal body-weight gain was maintained.
- Sex Consistency: MIRA-55 demonstrated comparable pain-relieving activity in both male and female animals.
The company noted that these results build upon previous preclinical studies where MIRA-55 normalized pain responses and reduced inflammation in an acute model, outperforming injected morphine in that specific study.
MIRA Pharmaceuticals stated that the findings further support its preclinical development profile and the advancement of MIRA-55 toward an Investigational New Drug (IND) submission. The company plans to file the IND in the first quarter of 2027, subject to the completion of remaining preclinical and regulatory activities.
MIRA-55 is described as a next-generation oral synthetic cannabinoid analog designed to modulate cannabinoid receptor pathways involved in pain signaling and inflammation. The U.S. Drug Enforcement Administration has determined that MIRA-55 is not a controlled substance.
