SKNY-1 / MIRA Pharma - LARVOL DELTA

MIRA Pharmaceuticals Progresses...SKNY-1 Toward IND-Enabling Studies (The Manila Times) - "Current CMC efforts include analytical, formulation, and manufacturing development activities intended to support future GLP-compliant toxicology studies and subsequent clinical development...In parallel, the Company has completed the in-life dosing and scheduled necropsy phases of exploratory, non-GLP, 7-day repeated-dose toxicology and toxicokinetic studies evaluating...SKNY-1 in both Sprague Dawley rats and Beagle dogs....These exploratory studies are designed to provide information regarding tolerability, systemic exposure and dose selection to help inform the design of future GLP-compliant IND-enabling toxicology studies. Sample analysis, toxicokinetic evaluation and histopathology remain ongoing."

Preclinical • Obesity

SKNY-1, a THCV Analog, Produces Weight Loss, Lipid Normalization and Attenuation of Reward-Associated Behaviors in an mc4r(G894C) Zebrafish Model of Obesity. (PubMed, Int J Mol Sci) - "The lower dose (20 ng per fish per day) more effectively normalized the leptin a-to-ghrelin expression ratio. Collectively, these findings demonstrate that SKNY-1 engages integrated endocannabinoid and potential dopaminergic mechanisms to improve metabolic parameters and attenuate maladaptive reward-related behaviors in an MC4R-deficient vertebrate model, supporting its further translational investigation for obesity complicated by compulsive eating and substance-seeking behaviors."

Journal • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Obesity • Psychiatry • LEP • MC4R

MIRA Pharmaceuticals Shareholders Approve Acquisition of SKNY Pharmaceuticals, Advancing Next-Generation Oral Therapeutic for Obesity… (ACCESS Newswire) - "Under the terms of the definitive agreement, the acquisition will be structured as a share exchange, with SKNY shareholders receiving shares of MIRA common stock in exchange for their SKNY shares....SKNY transaction strengthens MIRA pipeline with SKNY-1, a differentiated oral candidate that has demonstrated up to 30% weight loss...in preclinical studies."

M&A • Obesity

MIRA Reports Clear Reversal of Anxiety-Related Behavior in Animal Model Using SKNY-1, an Oral Drug Candidate for Obesity and Nicotine Addiction Under Definitive Agreement for Acquisition (Firstwordpharma Press Release) - "MIRA Pharmaceuticals...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 (CB1) 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 (CNS) effects....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."

Preclinical • Obesity