ASCLETIS-B (01672) announced that its Board of Directors has selected its first oral amylin receptor agonist peptide, ASC36 oral tablets, for clinical development. The company anticipates submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026 for ASC36 oral tablets for the treatment of obesity. The ASC36 oral tablet was developed by ASCLETIS using its proprietary oral peptide delivery enhancement technology (POTENT).
In non-human primates, a 10 mg ASC36 oral tablet administered once daily per animal for 7 days achieved an absolute oral bioavailability of 8% at steady state, with an elimination half-life of 116 hours. A 25 mg ASC36 oral tablet administered under the same conditions achieved an absolute oral bioavailability of 6% at steady state, with an elimination half-life of 167 hours. The long elimination half-life of ASC36 oral tablets, ranging from 116 to 167 hours, supports a once-daily or even less frequent oral dosing regimen.
ASC36 oral tablets demonstrated significant weight reduction effects in both non-human primate and diet-induced obese (DIO) rat models. In non-human primates, once-daily administration of ASC36 oral tablets for 7 days resulted in a mean body weight reduction of up to 13.2% from baseline. ASC36 tablets also significantly reduced food intake. In a head-to-head DIO rat model study, after 7 days of treatment, ASC36 achieved approximately 32% and 91% greater weight reduction compared to eloralintide and petrelintide, respectively.
Compared to a recently FDA-approved GLP-1R agonist peptide, ASC36 oral tablets are expected to require a lower dosage due to potentially superior oral bioavailability and efficacy. The superior weight reduction effect per milligram of ASC36 peptide may also confer scalability advantages in manufacturing.
ASC36 is an amylin receptor agonist peptide independently developed by ASCLETIS using its structure-based AI-assisted drug discovery (AISBDD) technology. The ASC36 oral tablet was developed and optimized by ASCLETIS using its proprietary POTENT technology, which is designed to enable oral peptide delivery.
"We have three key amylin candidates: an oral small molecule amylin, an oral amylin peptide, and a once-monthly subcutaneous amylin peptide. The ASC36 oral tablet is an important amylin agonist among them," said Dr. Jinzi J. Wu, Founder, Chairman, and CEO of ASCLETIS. "Leveraging our three proprietary technology platforms, including AISBDD, the Ultra-Long-Acting Platform (ULAP), and POTENT, ASCLETIS has successfully built a highly competitive, differentiated, and diversified product pipeline, poised to effectively address the diverse treatment needs of patients with obesity and other metabolic diseases."
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