Goli Pharmaceutical-B (01672) announced that its GLP-1 oral small molecule ASC30 has initiated global phase III clinical research and published positive preclinical data on its first-of-its-kind oral small molecule GLP-1/GIP/pancreatin fixed-dose combination

According to the Zhitong Finance App, Goli Pharmaceutical-B (01672) issued an announcement that the small molecule GLP-1 (ASC30) taken orally once a day has been approved for phase III clinical research by the US Food and Drug Administration (FDA). ASC30 is the core pillar of Geli's oral small molecule obesity treatment pipeline. The company has initiated a global phase III clinical program for ASC30 long-term weight management indications. The program consists of two key multicenter, randomized, double-blind, placebo-controlled global phase III trials (AURORA-1 NCT07743463 and AURORA-2 NCT07743450), which will enroll approximately 4,600 obese or overweight subjects in the US, Europe and Canada. These two key studies will evaluate the long-term efficacy, safety, and tolerability of taking three oral maintenance doses (20 mg, 40 mg, and 60 mg) of ASC30 versus placebo once daily in non-type 2 diabetic obese or overweight subjects (AURORA-1) and obese or overweight subjects with type 2 diabetes (AURORA-2). The treatment cycle for AURORA-1 and AURORA-2 was 72 weeks, and the titrations (titrations) for the 20 mg, 40 mg, and 60 mg maintenance dose groups were 12 weeks, 16 weeks, and 20 weeks, respectively. The company is expected to release top-line data for the ASC30 phase III clinical program in the third quarter of 2028, and plans to submit a new drug marketing application (NDA) to the US FDA at the end of 2028 and a marketing license application (MAA) to the European Medicines Agency (EMA) in early 2029. If approved by relevant regulators in the US and Europe, ASC30 is expected to become the second oral small molecule GLP-1 approved in the US and Europe after Orforglipron. The company has sufficient cash on hand to cover the expected submission of ASC30 NDAs and MAAs, and to support the company's operations until 2029.

Goli also published positive data on its first-in-class (first-in-class) fixed-dose combination formulation (FDC) of the small molecule GLP-1/GIP/pancreatin triple-target agonist taken orally once a day. The addition of the three-target agonist FDC enabled Geli to have a very comprehensive and advanced oral small molecule pipeline for the treatment of obesity and other metabolic diseases (Table 1). The pipeline includes: a best-in-class (best-in-class) oral small molecule GLP-1 in phase III clinical phase; a first-of-its-kind oral small molecule GLP-1/GIP dual-target agonist FDC (the world's first oral small molecule compound preparation similar to tilbopeptide+eloralintide); and a first-in-class once-daily oral small molecule GLP-1/GIP/ pancreatin three-target agonist FDC (the world's first oral small molecule compound similar to tirbopeptide+eloralintide) preparation); and a A first-of-its-kind small-molecule eloralintide-like selective insulin receptor agonist (SARA) that is taken orally once a day. This comprehensive pipeline combination gives Geli a unique competitive advantage and can significantly expand the number of people who can receive oral medication.

“We recently received positive feedback from the FDA on the ASC30 project End-of-Phase II, and then launched the ASC30 Global Phase III program, which is very exciting. “ASC30 is a central pillar in our once-daily, one-tablet-at-a-time oral portfolio for obesity treatment.” Dr. Wu Jinzi, founder, chairman of the board of directors and CEO of Geli said, “ASC30 (GLP-1), ASC48 (GIP), and ASC39 (insulin SARA) are small molecules with different physicochemical properties. In developing fixed-dose compound formulations (FDCs) with these molecules, we have successfully overcome many technical challenges. “The latest data on our first-of-its-kind oral triple-target (GLP-1, GIP/amylocretin) fixed-dose compound formulations further solidify our industry-leading, comprehensive, and differentiated once-a-day oral small molecule pipeline for treating obesity and other metabolic diseases.”