Mira Pharmaceuticals reports preclinical data on Mira-55 marijuana analog

MIRA Pharmaceuticals (MIRA) announced preclinical data demonstrating that Mira-55, the Company’s proprietary non-psychotropic marijuana analog, delivered morphine-comparable pain relief in a validated model of inflammatory pain-without causing local inflammation. Mira-55 is a next-generation analog of marijuana, engineered to selectively activate CB2 cannabinoid receptors, which are associated with anti-inflammatory and analgesic effects. Unlike THC, Mira-55 minimizes activation of CB1 receptors, reducing the risk of euphoria, sedation, and pro-inflammatory side effects. Mira-55 was tested using the formalin model, a gold-standard preclinical method for studying inflammatory pain. In this model, formalin is injected into the rat’s paw, producing a pain response that mimics human inflammatory pain. Pain sensitivity was assessed using Von Frey Filament testing, which measures tactile pain thresholds, and inflammation was measured by paw edema volume. Mira-55 reduced pain sensitivity by approximately threefold, restoring thresholds to near-baseline levels. Its analgesic effect was equivalent to morphine, the standard opioid comparator in the study. No sedation or inflammatory swelling was observed with Mira-55 treatment. Importantly, following a scientific review, the U.S. Drug Enforcement Administration determined that Mira-55 is not classified as a controlled substance. This designation supports the compound’s long-term clinical and commercial viability and removes key barriers typically associated with cannabinoid-based drug development. These results build on prior data from a separate inflammatory pain model conducted by a leading U.S. academic research center, where Mira-55 blocked both thermal and mechanical hyperalgesia without increasing inflammation. In contrast, low-dose THC in that model exacerbated inflammation-further validating Mira-55’s selective pharmacological profile. MIRA Pharmaceuticals is advancing Mira-55 toward an Investigational New Drug (IND) submission, with ongoing activities supporting future clinical development in inflammatory pain. The Company remains focused on progressing both lead programs-Mira-55 and Ketamir-2-toward their next regulatory and clinical milestones.