MIRA Pharmaceuticals Announces New Data for Mira-55, No CNS Side Effects Observed
MIRA Pharmaceuticals announced new preclinical data demonstrating that Mira-55 did not produce cannabinoid-like central nervous system side effects across a comprehensive battery of validated behavioral assays. The observed profile was differentiated from both undefined9-tetrahydrocannabinol, the primary psychoactive component of cannabis, and the CB1 receptor antagonist rimonabant. These findings build on previously reported preclinical data demonstrating that Mira-55 delivered morphine-comparable pain relief in a validated model of inflammatory pain, without opioid-related risks. Collectively, these data support the Company's ongoing efforts to advance Mira-55 toward an Investigational New Drug submission for inflammatory pain. The study, conducted in collaboration with Pharmaseed, evaluated Mira-55 at oral doses of 10, 30, and 100 mg/kg and compared its behavioral effects to THC and rimonabant using established assays commonly employed to assess cannabinoid-related CNS and behavioral effects, including: Hypothermia; Catalepsy; Elevated Plus Maze; Open Field. Key Observations: No cannabinoid-like psychogenic effects were observed at any tested dose of Mira-55; No evidence of sedation, catalepsy, or motor impairment, differentiating Mira-55 from CB1-active compounds such as rimonabant; No anxiogenic effects were observed, in contrast to rimonabant, which demonstrated anxiety-like behavioral changes; In the Elevated Plus Maze, Mira-55 showed a dose-dependent increase in time spent in open arms, consistent with reduced anxiety-like behavior; In Open Field testing, Mira-55-treated groups were comparable to vehicle controls, indicating no detectable adverse behavioral effects. Rimonabant-treated groups demonstrated reduced time spent in the center of the open field, a commonly used indicator of anxiety-like behavior, supporting the sensitivity of the experimental model. The CNS safety findings complement previously reported preclinical efficacy data demonstrating that Mira-55: Reduced pain sensitivity and restored thresholds to near-baseline levels in inflammatory pain models; Demonstrated morphine-comparable analgesic effects in a validated inflammatory pain model; Did not produce sedation or opioid-like adverse effects; Did not induce inflammatory swelling, supporting a differentiated profile versus certain comparator agents. While these findings are based on preclinical models, they support a differentiated pharmacological profile for Mira-55.
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Pre-Market Stock Movements: Several stocks experienced significant movements in pre-market trading, with Global Interactive Technologies surging 217.7% and Fly-E Group tumbling 25.8% following a reverse stock split announcement.
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Regulatory Advancements and Future Prospects: The DEA confirmed that Mira-55 is not a controlled substance, facilitating its clinical development, while the company also progresses with other pain management therapies and an acquisition aimed at enhancing its market position.
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