Citi: Ascletis Pharma's oral GLP-1 phase II data are positive; phase III plans expected to be discussed with FDA soon

What were the blood glucose results in the phase II trial?

The company announced the main results of a 13-week US phase II trial of ASC30, an oral small-molecule GLP-1 drug. The trial enrolled 100 patients with type 2 diabetes.
Patients had a mean baseline glycated haemoglobin level of 8.3%. By week 12, the 40, 60 and 80 mg dose groups achieved placebo-adjusted reductions in glycated haemoglobin of 1.7, 1.6 and 1.7 percentage points, respectively. The results were statistically significant for all three doses.

By week 13, the 40, 60 and 80 mg groups achieved placebo-adjusted weight reductions of 4.4%, 3.8% and 4.0%, respectively, with no weight loss plateau observed.
Citi said safety and tolerability were favourable despite weekly dose escalation: there were no drug-related serious adverse events and no liver safety signals were observed. On that basis, the bank believes the phase II data support ASC30's best-in-class potential.

Citi expects the company to discuss the phase III trial with the US FDA soon, with the discussions potentially finalising the phase III doses. The bank maintains its Buy and High Risk ratings and a target price of 31 Hong Kong dollars.
The target price uses a discounted cash flow model incorporating revenue and earnings forecasts through 2037. The company is not yet profitable; the key risks listed by Citi include clinical trial failure for ASC30 or ASC47, and sales below expectations.