Key Takeaways:
Ascletis Pharma received US Food and Drug Administration clearance to start a global Phase III program for ASC30, an oral small-molecule GLP-1, enrolling about 4,600 patients with obesity or overweight.
"Following recent positive end-of-Phase II feedback received from the FDA for ASC30, we are excited to have initiated the global Phase III program of ASC30, the primary pillar of our one-pill once-daily oral small molecule obesity portfolio," Jinzi Jason Wu, founder, chairman and chief executive officer at Ascletis, said.
The program comprises two pivotal, multicenter, randomized, double-blind, placebo-controlled trials — AURORA-1 (NCT07743463) and AURORA-2 (NCT07743450) — running in the US, Europe and Canada. Both test three maintenance doses of once-daily oral ASC30 (20 mg, 40 mg and 60 mg) against placebo over 72 weeks, with titration periods of 12 to 20 weeks depending on the dose cohort. AURORA-1 enrolls patients without type 2 diabetes; AURORA-2 includes those with the condition.
Ascletis expects topline data in the third quarter of 2028, a US New Drug Application filing by the end of 2028 and a European Medicines Agency Marketing Authorisation Application in early 2029. If approved, ASC30 would become the second oral small-molecule GLP-1 cleared in the US and Europe after Eli Lilly's orforglipron. The Hong Kong-listed shares rose 7.8 percent on the announcement, and the company said cash on hand supports operations into 2029, beyond the expected submissions.
Preclinical data across the portfolio
Ascletis also reported positive preclinical results for its first-in-class once-daily oral small-molecule GLP-1/GIP/amylin triple agonist fixed-dose combination, ASC30_48_39FDC. In non-human primates, seven days of treatment produced a body weight reduction of up to 15.2 percent, up to 120 percent greater than the dual agonist combination ASC30_39FDC, with the GIP component ASC48 driving the effect. The company positions the triple as the oral equivalent of injectable combinations such as tirzepatide plus eloralintide, which cut body weight 29 percent at week 32 in a study disclosed at EASD 2026.
The dual agonist ASC30_48FDC cut body weight 10.5 percent in non-human primates after eight days, 52 percent more than ASC30 monotherapy, while the selective amylin receptor agonist ASC39 showed 40-fold selectivity for the human amylin 1 receptor over the calcitonin receptor and a 6.0 percent weight loss in obese rats, comparable to eloralintide. Ascletis plans investigational new drug filings for ASC39 and ASC30_39FDC in the third quarter of 2026 and for ASC30_48FDC and ASC30_48_39FDC in the fourth quarter.
The Phase III start gives Ascletis a shot at the oral obesity market now dominated by injectable GLP-1s from Eli Lilly and Novo Nordisk, with orforglipron the only oral small-molecule competitor expected ahead of it. Investors will watch the AURORA-1 and AURORA-2 topline readout in the third quarter of 2028 as the next catalyst for the stock.
This article is for informational purposes only and does not constitute investment advice.
