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Ascletis Pharma Inc., a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases, announces recent submissions of two Investigational New Drug (IND) applications to the US Food and Drug Administration (FDA) for ASC36, a once-monthly to once-quarterly next-generation peptide amylin receptor agonist and ASC36_35 FDC, a once-monthly injection co-formulation of ASC36 plus peptide GLP-1R/GIPR agonist ASC35, for the treatment of obesity.
“Eloralintide in combination with tirzepatide recently demonstrated 29.0% weight loss at week 32. However, two separate weekly injections are required; one for eloralintide and one for tirzepatide. In contrast, ASC36_35 FDC, a potentially first-in-class subcutaneous (SQ) injection co-formulation targeting amylin receptor, GLP-1R and GIPR, requires only one monthly injection,” said Jinzi Jason Wu, Ph.D., founder, chairman and CEO of Ascletis, “Equally exciting, ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide in a head-to-head diet-induced obese (DIO) rat study. These animal models are highly predictive of human efficacy.”
Both ASC36 and ASC35 were discovered in-house utilizing Ascletis’ Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD). Both ASC36 once-monthly to once-quarterly formulation and ASC36_35 FDC once-monthly co-formulation are Self-Assembling Lipid Depot (SALD) formulations, developed in-house utilizing Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.
In head-to-head non-human primate (NHP) studies, ASC36 SALD formulation demonstrated approximately 6-fold longer observed half-life than eloralintide, supporting once-monthly to once-quarterly SQ administration in humans. In NHP studies, ASC36_35 FDC SALD co-formulation demonstrated long observed half-lives for both ASC36 and ASC35, supporting once-monthly SQ administration in humans.
Preclinical studies have established the superior efficacy of ASC36 injection and ASC36_35 FDC injection co-formulation. In head-to-head DIO rat studies, which are highly predictive of human efficacy, ASC36 monotherapy, targeting amylin receptor, demonstrated approximately 91% and 32% greater relative body weight reduction compared to petrelintide and eloralintide monotherapies, respectively. In head-to-head DIO rat studies, the ASC36_35 co-formulation, targeting three targets of amylin receptor, GLP-1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared to the co-administration of eloralintide and tirzepatide.
Both ASC36 injection formulation and ASC36_35 FDC injection co-formulation exhibit excellent chemical and physical stability with no aggregation or precipitation caused by fibrillation at neutral pH.
Two IND submissions for ASC36 once-monthly injection and ASC36_35 once-monthly injection co-formulation build upon the recent milestone achieved by ASC35 once-monthly SALD formulation. In June 2026, Ascletis announced US FDA IND clearance to initiate a phase I clinical trial for ASC35 as a once-monthly SQ treatment for obesity, highlighting the Company's robust clinical execution and the potential of its ULAP technology.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead programme, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, ASC39, an eloralintide-like potent and amylin-selective oral small molecule amylin receptor agonist, and ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30 (GLP-1RA) and ASC39 (amylin RA), for chronic weight management.
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