ASCLETIS-B (01672.HK): IND for Oral Obesity Drug ASC39 Filed with US FDA

NewTimeSpace News: On 26 October 2026, Ascletis Pharma Inc. (stock code: 1672) published a voluntary announcement that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for ASC39 tablets, an oral small-molecule selective amylin receptor agonist for the treatment of obesity. The Company expects to start a Phase I trial in the fourth quarter of 2026.

ASC39 has a distinctive chemical scaffold discovered independently using the Company's artificial intelligence-assisted structure-based drug discovery (AISBDD) technology. In head-to-head cAMP activation assays against eloralintide, the half-maximal effective concentrations of ASC39 and eloralintide were 21.4 pM and 21.2 pM at the human amylin 1 receptor (hAMY1R), and 846.1 pM and 1,350.8 pM at the human calcitonin receptor (hCTR) respectively; accordingly, ASC39 is 40-fold more selective for hAMY1R over hCTR, versus 64-fold for eloralintide.

In a diet-induced obese rat study, once-daily oral ASC39 at 5 mg/kg for six consecutive days produced a placebo-adjusted body weight reduction of 6.6%. ASC39 showed favourable pharmacokinetics in rats and non-human primates, supporting once-daily oral dosing in humans. The Company said ASC39 is the only oral small-molecule selective amylin receptor agonist in development, acting selectively on the amylin receptor rather than the calcitonin receptor, unlike non-selective dual agonists.

ASC39 is being developed both as a monotherapy and in combination with the oral small molecule ASC30, which is in two pivotal global Phase III studies. The Company's amylin pipeline also includes ASC36, a quarterly subcutaneous and weekly oral amylin agonist peptide.