ASCLETIS-B (01672): Submits an Investigational New Drug application to the U.S. FDA for ASC30_39 FDC for the treatment of obesity, which has the potential to become a first-in-class fixed-dose combination of an oral small-molecule GLP-1R agonist and a selective amylin receptor agonist

ASCLETIS-B (01672) announced that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC30_39 FDC for the treatment of obesity. ASC30_39 FDC is a once-daily oral fixed-dose combination (FDC) tablet of the small-molecule GLP-1R agonist ASC30 and the small-molecule selective amylin receptor agonist (SARA) ASC39. "ASC30_39 FDC is the first oral GLP-1 and oral amylin combination to have an IND submitted, combining two validated and complementary weight management mechanisms in a once-daily tablet," said Dr. Jinzi J. Wu, Founder, Chairman and Chief Executive Officer of Ascletis. "By combining the potentially best-in-class efficacy and gastrointestinal tolerability of ASC30 with the first eloralintide-like oral small-molecule amylin, we believe ASC30_39 FDC has the potential to offer a highly differentiated and convenient oral treatment option for patients with obesity." This IND submission builds on recent milestones in Ascletis' oral small-molecule pipeline. ASC30 is currently being evaluated in two global pivotal Phase III studies (AURORA-1 and AURORA-2), enrolling approximately 4,600 subjects with obesity or overweight in the United States, Europe and Canada. Ascletis expects to report topline data from the AURORA Phase III clinical program in the third quarter of 2028. Ascletis recently announced that it has submitted an IND to the U.S. FDA for its oral small-molecule selective amylin receptor agonist ASC39 for the treatment of obesity.