MIRA Pharmaceuticals (NASDAQ: MIRA) has announced positive results from 7-day toxicology studies of MIRA-55, an oral, non-opioid drug being developed to treat inflammatory pain. The studies were conducted in rats and dogs and were designed primarily to determine appropriate doses for the more rigorous toxicology studies required before MIRA can begin testing the drug in humans.

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The results showed that rats were more sensitive to MIRA-55, while dogs tolerated higher doses. More importantly, researchers were able to measure how much of the drug entered the bloodstream at different doses and after repeated administration.

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That's basically what MIRA needed from these studies.

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The company can now use those results to select doses for its next round of GLP-compliant toxicology testing. Assuming those studies go as planned, MIRA is targeting an Investigational New Drug application with the FDA in the first quarter of 2027. An IND clearance would allow MIRA-55 to move into human clinical trials.

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What exactly is MIRA-55?

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MIRA-55 is interesting because it targets cannabinoid receptors involved in both pain and inflammation, but it's designed to avoid the psychoactive effects associated with THC.

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Previous animal studies showed that oral MIRA-55 reduced inflammation and normalized pain responses in an inflammatory pain model. According to MIRA, it actually outperformed injected morphine in normalizing pain responses in that particular preclinical model.

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The DEA has also determined that MIRA-55 is not a controlled substance, which could eliminate some of the regulatory and commercial complications associated with opioid and certain cannabinoid-based drugs.

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Still very early

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There's clearly a large market if MIRA-55 eventually works.

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About 24.3% of U.S. adults experienced chronic pain in 2023, while 8.5% experienced high-impact chronic pain that frequently interfered with their lives or ability to work.

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But keep the development timeline in perspective.

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MIRA-55 hasn't entered Phase 1 yet. Today's toxicology results don't tell us whether the drug will work in people. What they do tell us is that MIRA has cleared another preclinical development step and remains on track toward an IND submission.

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For a small biotech like MIRA, that's meaningful progress. 

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