Mira Pharmaceuticals reports preclinical data on SKNY-1 candidate

MIRA Pharmaceuticals (MIRA) announced new preclinical results from SKNY-1, an oral drug candidate for obesity and nicotine addiction currently under definitive agreement for acquisition. In a validated behavioral model used to measure Cannabinoid 1 receptor related anxiety-like effects, SKNY-1 demonstrated clear reversal of anxiety-related behavior induced by a CB1 activator, setting it apart from earlier CB1-targeting drugs that were discontinued due to serious central nervous system effects. SKNY-1 is being developed as a potential oral treatment for obesity and addiction. It has previously been shown to achieve up to 30% weight loss, reverse high-calorie food and nicotine cravings, and preserve muscle mass in preclinical models. These new findings suggest that SKNY-1 may deliver these therapeutic effects without emotional or behavioral disruption, an important factor in long-term treatment adherence. The study used the light-dark preference test in zebrafish-a validated behavioral model to assess anxiety-related responses. Zebrafish naturally prefer darker environments due to an innate fear of predators. However, when anxiety levels are elevated, they avoid the light even more strongly spending more time in the dark. Reduced dark preference is interpreted as a calming effect.Four groups were evaluated: Control Group: Fish showed balanced behavior between light and dark environments. CP55,940 Group: These animals spent significantly more time in the dark, confirming that CB1 activation increases anxiety at higher doses. Interestingly, at lower doses, CP55,940 produced a calming effect-reducing dark preference and encouraging exploration of the light area. Rimonabant Group: Fish treated with Rimonabant also showed increased dark-zone time and exhibited a greater increase in anxiety-like behavior than the CB1 agonist group, under both high and low doses of agonist-consistent with the known psychiatric effects that led to Rimonabant’s market withdrawal. SKNY-1 Groups: In animals co-treated with CP55,940, SKNY-1 significantly reversed the anxiety-inducing effects of high-dose CP55,940 and enhanced the calming effects at low doses. In all conditions, SKNY-1 brought anxiety-like behavior back to control or better-than-control levels. These results suggest SKNY-1 may help stabilize mood and stress-related behavior-a potential advantage in treating both metabolic and addictive disorders. MIRA is currently preparing for shareholder approval related to the proposed acquisition of SKNY Pharmaceuticals, Inc. Pending approval, the Company expects to initiate Investigational New Drug-enabling studies for SKNY-1 as a next step toward human clinical trials.