ASC30_39 FDC, a once-daily oral fixed-dose combination (FDC) tablet of small molecule GLP-1R agonist ASC30 and small molecule selective amylin receptor agonist ASC39, is the first co-formulation of an oral GLP-1 and an oral amylin to reach Investigational New Drug submission.

ASC30_39 FDC demonstrated highly favorable pharmacokinetics with excellent oral bioavailability, high drug exposure and a long half-life.

ASC30 is a once-daily oral small molecule GLP-1R agonist currently in two global pivotal Phase III studies (AURORA-1 and AURORA-2).

ASC39 demonstrated eloralintide-like amylin selectivity (40-fold for hAMY1R over hCTR) and efficacy in preclinical models.

ASC30_39 FDC demonstrated excellent compatibility between ASC30 and ASC39, with room temperature stability and a small pill size.

Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC30_39 FDC, a once-daily oral fixed-dose combination (FDC) tablet of small molecule GLP-1R agonist ASC30 and small molecule selective amylin receptor agonist (SARA) ASC39, for the treatment of obesity.

"ASC30_39 FDC is the first co-formulation of an oral GLP-1 and an oral amylin to reach IND submission, combining two validated, complementary mechanisms for weight management in a single once-daily tablet." said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "By pairing 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 patients a highly differentiated and convenient oral treatment option for obesity."

The IND submission builds upon the recent milestones of Ascletis' oral small molecule portfolio. ASC30 is currently in two global pivotal Phase III studies (AURORA-1 and AURORA-2), enrolling approximately 4,600 participants with obesity or overweight in the U.S., 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 the submission of an IND to the U.S. FDA for ASC39, its oral small molecule selective amylin receptor agonist, for the treatment of obesity.