Ascletis Pharma Inc. (1672) announced the selection of its first oral amylin receptor peptide agonist, ASC36, for clinical development. The company plans to submit an Investigational New Drug Application to the U.S. Food and Drug Administration for the treatment of obesity in the second quarter of 2026.
ASC36 oral tablets were developed using the proprietary Peptide Oral Transport ENhancement Technology (POTENT). In non-human primate (NHP) studies, once-daily dosing for seven days demonstrated an absolute oral bioavailability ranging from 6% to 8% and an elimination half-life between 116 and 167 hours at steady state. ASC36 oral tablets also reduced mean body weight by as much as 13.2% in NHPs and significantly lowered food intake over the same period.
In a head-to-head diet-induced obese (DIO) rat model, ASC36 achieved approximately 32% and 91% greater relative body weight reduction compared to eloralintide and petrelintide, respectively. Due to potentially better oral bioavailability and efficacy, ASC36 tablets are expected to utilize a lower dose, offering possible scalability advantages in manufacturing.
ASC36 was discovered and developed in-house using Artificial Intelligence-assisted Structure-Based Drug Discovery, with the tablet formulation optimized through POTENT. Ascletis also employs other technology platforms to address various treatment needs for obesity and related metabolic conditions.
The announcement includes a cautionary statement that there is no guarantee of successfully developing, manufacturing, or commercializing ASC36 in the future.
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