MIRA Pharma Reports 21-Day Preclinical Proof-Of-Concept Study Showing That Once-Daily Oral MIRA-55 Significantly Reduced Mechanical And Thermal Pain Hypersensitivity; Results Back MIRA-55's Progress Toward IND Filing

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapies for neurologic, inflammatory and metabolic disorders, today announced positive results from a 21-day preclinical proof-of-concept study evaluating oral MIRA-55 in a validated model of chronic inflammatory pain. The results support the continued advancement of MIRA-55 toward an Investigational New Drug (IND) submission.

The study demonstrated that once-daily oral MIRA-55 significantly reduced both mechanical and thermal pain hypersensitivity (p < 0.001 versus vehicle) as from the lowest dose used. MIRA-55 achieved pain-relieving effects comparable in magnitude to celecoxib (Celebrex®), a widely prescribed medication for pain and inflammation, at the higher doses evaluated.

Importantly, the effects were maintained throughout the three-week study without evidence of tolerance. MIRA-55 also reduced inflammation-associated swelling and was well tolerated, with no adverse clinical signs observed during repeated daily administration.

These findings build on MIRA's earlier preclinical studies, including previously reported results demonstrating that oral MIRA-55 normalized pain responses and reduced inflammation in an acute inflammatory pain model, outperforming injected morphine in that study. Together, these findings extend MIRA-55's demonstrated preclinical analgesic activity into a model of persistent, chronic inflammatory pain, further supporting its development as a next-generation oral therapy designed to provide effective, long-term pain relief with an improved safety and tolerability profile.

Key Study Highlights

• Significant Pain Relief: MIRA-55 significantly reduced both mechanical and thermal pain hypersensitivity compared with vehicle-treated animals (p < 0.001).
• Comparable to Celebrex: MIRA-55 demonstrated pain-relieving effects comparable in magnitude to celecoxib, with no statistically significant differences observed between those treatments.
• Sustained Efficacy Without Observed Tolerance: Pain relief was maintained throughout the three-week study, with no observed decline in effectiveness during repeated daily dosing.
• Reduced Inflammation-Associated Swelling: MIRA-55 reduced paw swelling to a similar magnitude as the reduction observed with celecoxib.
• Consistent Results Across Both Sexes: MIRA-55 demonstrated comparable pain-relieving activity in male and female animals.
• Favorable Observed Tolerability: No adverse clinical signs or deaths were reported, and normal body-weight gain was maintained throughout the treatment period.