Utilizing Ascletis' Peptide Oral Transport ENhancement Technology (POTENT), ASC36 oral tablets achieved absolute oral bioavailability of 6% to 8% at steady state, in non-human primate (NHP) studies.

-   In NHPs, ASC36 oral tablets reduced mean body weight up to 13.2% from baseline after once-daily dosing for 7 days. ASC36 tablets also reduced food intake significantly.

-   In a head-to-head diet-induced obese (DIO) rat model, ASC36 demonstrated approximately 32% and 91% greater relative body weight reduction compared to eloralintide and petrelintide, respectively.

-   ASC36 oral tablets are expected to utilize a lower dose due to potentially better oral bioavailability and efficacy. This superior weight loss per milligram of ASC36 peptide may also provide scalability advantages in manufacturing.

-   Submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC36 oral tablets is expected in the second quarter of 2026.

 Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC36 oral tablets, its first oral amylin receptor peptide agonist, for clinical development. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC36 oral tablets for the treatment of obesity in the second quarter of 2026.

ASC36 oral tablets were developed with Ascletis' proprietary Peptide Oral Transport ENhancement Technology (POTENT). In non-human primates (NHPs), 10 mg ASC36 oral tablet per animal dosed once daily for 7 days achieved absolute oral bioavailability^[1] of 8% and elimination half-life of 116 hours at steady state; 25 mg ASC36 oral tablet per animal dosed once daily for 7 days  achieved absolute oral bioavailability of 6% and elimination half-life of 167 hours at steady state. The long elimination half-life (116 hours to 167 hours) of ASC36 oral tablets supports once-daily and less frequent oral dosing.

ASC36 oral tablets demonstrated significant weight loss in both NHP and diet-induced obese (DIO) rat models. In NHPs, ASC36 oral tablets reduced mean body weight up to 13.2% from baseline after once-daily dosing for 7 days. ASC36 tablets also reduced food intake significantly.

In a head-to-head DIO rat model, after 7 days of treatment, ASC36 demonstrated approximately 32% and 91% greater relative body weight reduction compared to eloralintide and petrelintide, respectively. 

ASC36 oral tablets are expected to utilize a lower dose, relative to a recently FDA approved oral GLP-1R peptide agonist, due to potentially better oral bioavailability and efficacy. This superior weight loss per milligram of ASC36 peptide may also provide scalability advantages in manufacturing.

ASC36, an amylin receptor peptide agonist, was discovered and developed in-house utilizing Ascletis' Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD). ASC36 oral tablet formulation was developed and optimized by Ascletis' POTENT technology for delivery of oral peptides.

"ASC36 oral tablets is an important amylin agonist among three key amylin drug candidates, i.e. an oral small molecule amylin, an oral peptide amylin and a once-monthly subcutaneous injectable peptide amylin," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. "Leveraging our three proprietary technology platforms, including AISBDD, Ultra-Long-Acting Platform (ULAP) and POTENT, Ascletis has successfully established a highly competitive, differentiated and diverse pipeline portfolio which can potentially effectively address the various treatment needs of patients with obesity and other metabolic diseases."