Ascletis Pharma-B (01672) has submitted two Investigational New Drug (IND) applications to the U.S. FDA for the treatment of obesity: ASC36, a peptide amylin receptor agonist, and ASC36_35, a combination injection of ASC36 and the peptide GLP-1R/GIPR agonist ASC35. – Phoenix News

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Special Notice: The above content (including any videos, images, or audio) is uploaded and published by a user of Dafeng Hao, a self-media platform under Phoenix. com. This platform only provides information storage space services. According to Zhitong Finance APP, Ascletis Pharma-B (01672) announced that it has recently submitted two Investigational New Drug (IND) applications to the U. S. Food and Drug Administration (FDA): a once-monthly to quarterly next-generation peptide amylin receptor agonist, ASC36, and ASC36_35 FDC, a once-monthly injectable combination of ASC36 and the peptide GLP-1R/GIPR agonist ASC35, for the treatment of obesity. “Recent data from Eloralintide combined with telpotetide showed a 29.0% weight loss at week 32. However, this regimen requires two injections per week, one of eloralintide and one of telpotetide. In contrast, ASC36_35 FDC, a subcutaneous combination targeting the amylin receptor, GLP-1R, and GIPR, which is expected to be a first-in-class drug, only requires one injection per month, ” said Dr. Jinzi Wu, founder, chairman, and CEO of Ascletis. “Equally exciting is that in a head-to-head diet-induced obesity (DIO) rat study, ASC36_35 FDC showed approximately 51% better weight loss than eloralintide combined with telpotetide. These animal models are highly predictive of human efficacy. ” Both ASC36 and ASC35 were independently developed by Ascletis using its structure-based AI-assisted drug discovery (AISBDD) technology. ASC36, administered monthly to quarterly, and ASC36_35 FDC, administered monthly, are both self-assembled lipid reservoir (SALD) formulations developed using Ascletis' proprietary Ultra-Long-Acting Drug Development Platform (ULAP) technology. In head-to-head non-human primate studies, The observed half-life of the ASC36 SALD formulation is approximately six times that of eloralintide, supporting once-monthly to quarterly subcutaneous administration in humans. In non-human primate studies, both ASC36 and ASC35 exhibit long observed half-lives in the ASC36_35 FDC SALD formulation, supporting once-monthly subcutaneous administration in humans. Preclinical studies have established the superior efficacy of ASC36 injection and the ASC36_35 FDC combination injection. In head-to-head DIO rat studies (highly predictive of human efficacy), ASC36 monotherapy targeting the amylin receptor showed approximately 91% and 32% relative improvements in weight loss compared to petrelintide monotherapy and eloralintide monotherapy, respectively. In a head-to-head DIO rat study, the ASC36_35 combination formulation targeted three targets: amylin receptor, GLP-1R, and GIPR, resulting in a weight loss effect approximately 51% higher than that of eloralintide combined with telpolide. Both ASC36 injection and ASC36_35 FDC combination injection exhibit superior physicochemical stability, showing no fibrosis-induced aggregation or precipitation near neutral pH. Building on the recent milestone achieved with the ASC35 SALD monthly formulation, we have submitted two INDs for ASC36 monthly injection and ASC36_35 combination monthly injection. In this announcement, Ascletis announced that its Phase I clinical trial of once-monthly subcutaneous ASC35 for the treatment of obesity has received IND approval from the US FDA, demonstrating the company's strong clinical development execution capabilities and the potential of its ULAP technology.