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MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) is having a good Tuesday. The company's stock is trading higher after it announced positive results from completed seven-day dose-range-finding toxicology and toxicokinetic studies of its lead drug candidate, MIRA-55, in rats and dogs.
MIRA-55 is an investigational oral, non-opioid drug candidate designed to treat inflammatory pain. The recent studies were designed to evaluate systemic exposure, toxicity, and tolerability across both animal species.
Researchers found that rats were the more sensitive species, while dogs showed higher tolerance levels across the dosages studied. The toxicokinetic analyses confirmed systemic exposure in both models, showing how exposure levels changed with dosage adjustments and repeated administration.
These findings met the trial's core objectives by providing cross-species metrics that will help guide dose selection for the next stages of the ongoing IND-enabling program. The company plans to use these results when designing upcoming GLP-compliant toxicology studies.
MIRA-55 addresses a significant demand in pain management. According to the Centers for Disease Control and Prevention, 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, with projections to grow to $70.3 billion by 2030, representing 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.
Alongside completing the 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.
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