MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) stock is trading higher on Tuesday following positive findings from completed seven-day dose-range-finding toxicology and toxicokinetic studies evaluating MIRA-55 in rats and dogs.
The investigational oral, non-opioid drug candidate targets inflammatory pain.
Cross-Species Study Results
The preclinical studies evaluated systemic exposure, toxicity, and tolerability across both animal species.
Researchers identified rats as the more sensitive species, whereas dogs displayed higher tolerance levels across the studied dosages.
Toxicokinetic analyses confirmed systemic exposure in both models, characterizing how exposure levels shifted with dosage adjustments and repeated administration.
These findings fulfilled the trial’s core objectives by establishing cross-species metrics to guide dose selection for subsequent stages of the ongoing IND-enabling program.
The company intends to apply these results when designing upcoming GLP-compliant toxicology studies.
Addressing Non-Opioid Market Demand
MIRA-55 addresses a significant demand in pain management. Centers for Disease Control and Prevention data indicates that 24.3% of U.S. adults suffered from chronic pain in 2023, with 8.5% experiencing high-impact chronic pain that limited work or daily activities.
Grand View Research estimates the global non-opioid pain-treatment market at $45.3 billion in 2024, projecting growth to $70.3 billion by 2030 at a compound annual growth rate of 7.7%.
In earlier preclinical testing, oral MIRA-55 normalized pain responses and reduced inflammation in a validated pain model, outperforming injected morphine in pain normalization.
MIRA considers this dual analgesic and anti-inflammatory activity a key market differentiator.
Clinical Development Timeline
Alongside completing dose-range studies, MIRA has progressed manufacturing scale-up and formulation efforts to prepare for clinical testing.
Pending successful completion of remaining IND-enabling studies and regulatory requirements, the company targets submitting an Investigational New Drug application to the U.S. Food and Drug Administration in the first quarter of 2027.
MIRA Price Action: Mira Pharmaceuticals shares were up 16.87% at $0.90 at the time of publication on Tuesday, according to Benzinga Pro data.
Image via Shutterstock
