ASCLETIS-B (01672) announced that its GLP-1 oral small molecule ASC30 has launched global Phase III clinical studies and released positive preclinical data for its first-in-class oral small molecule GLP-1/GIP/insulin fixed-dose combination formulation.

ASCLETIS-B (01672) announced that its once-daily oral small molecule GLP-1 (ASC30) has received approval from the U.S. Food and Drug Administration (FDA) for a Phase III clinical trial. ASC30 is the cornerstone of Eucure's oral small molecule obesity treatment pipeline. The company has initiated a global Phase III clinical program targeting the long-term weight management indication for ASC30, which consists of two pivotal multicenter, randomized, double-blind, placebo-controlled global Phase III trials (AURORA-1 NCT07743463 and AURORA-2 NCT07743450), enrolling approximately 4,600 obese or overweight participants across the U.S., Europe, and Canada. These two pivotal studies will evaluate the long-term efficacy, safety, and tolerability of ASC30 administered once daily at three maintenance doses (20 mg, 40 mg, and 60 mg) compared to placebo, in non-type 2 diabetic obese or overweight participants (AURORA-1) and in obese or overweight participants with type 2 diabetes (AURORA-2). Both AURORA-1 and AURORA-2 have a treatment period of 72 weeks, with titration periods for the 20 mg, 40 mg, and 60 mg maintenance dose groups set at 12 weeks, 16 weeks, and 20 weeks, respectively. The company expects to announce the top-line data of the ASC30 Phase III clinical program in the third quarter of 2028 and plans to submit a New Drug Application (NDA) to the U.S. FDA by the end of 2028, along with a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2029. If approved by the relevant regulatory authorities in the U.S. and Europe, ASC30 is expected to become the second oral small molecule GLP-1 approved in the U.S. and Europe, following orforglipron. The company has sufficient cash on hand to cover the anticipated submissions of the ASC30 NDA and MAA, which will support its operations through 2029. Eucure also announced positive data for its first-in-class once-daily oral small molecule GLP-1/GIP/amylin triagonist fixed-dose combination (FDC). The addition of this triagonist FDC provides Eucure with a very comprehensive and advanced oral small molecule pipeline for the treatment of obesity and other metabolic diseases (Table 1). This pipeline includes: a best-in-class once-daily oral small molecule GLP-1 currently in Phase III clinical stage; a first-in-class once-daily oral small molecule GLP-1/GIP dual agonist FDC (the world's first oral small molecule combination similar to tirzepatide); a first-in-class once-daily oral small molecule GLP-1/GIP/amylin triagonist FDC (the world's first oral small molecule combination similar to tirzepatide + eloralintide); and a first-in-class once-daily oral small molecule selective amylin receptor agonist (SARA) similar to eloralintide. This comprehensive pipeline combination gives Eucure a unique competitive advantage, significantly expanding the population eligible for oral drug treatments. Recently, we received positive feedback from the FDA regarding the ASC30 end-of-Phase II project, which led to the launch of the global Phase III project for ASC30this is very exciting. ASC30 is the cornerstone of our once-daily, one-tablet oral small molecule obesity treatment pipeline, said Dr. Jinzi Wu, founder, chairman of the board, and CEO of Eucure. ASC30 (GLP-1), ASC48 (GIP), and ASC39 (amylin SARA) are small molecules with different physicochemical properties. During the development of the fixed-dose combination (FDC) of these molecules, we successfully overcame numerous technical challenges. The latest data from our first-in-class oral small molecule triagonist (GLP-1/GIP/amylin) FDC further strengthens our leading, comprehensive, and differentiated once-daily, one-tablet oral small molecule pipeline for treating obesity and other metabolic diseases.