Biotechnology company Ascletis Pharma Inc (HKEX: 1672) reported on Wednesday that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for ASC30_39 FDC, a once-daily oral fixed-dose combination of small molecule GLP-1 receptor agonist ASC30 and selective amylin receptor agonist ASC39 for the treatment of obesity. The company said it is the first co-formulation of an oral GLP-1 and oral amylin agonist to reach IND submission.

Developed using Ascletis' proprietary formulation technology, ASC30_39 FDC demonstrated compatibility between the two compounds, room-temperature stability and a small tablet size. Preclinical studies in dogs showed high oral bioavailability, drug exposure and a half-life of up to 12 hours, consistent with the respective monotherapies.

Both compounds were discovered using Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery technology. ASC30 is currently being evaluated in two global Phase III trials, AURORA-1 and AURORA-2, involving approximately 4,600 participants with obesity or overweight. Topline results are expected in the third quarter of 2028.

ASC39 demonstrated 40-fold selectivity for the human amylin 1 receptor over the human calcitonin receptor and produced a 6.6% placebo-adjusted body weight reduction in preclinical studies in obese rats, comparable with eloralintide.