Ascletis Reports Positive Phase II Data for GLP-1 Agonist ASC30 and Advances ASC36 for Obesity

Ascletis Pharma has announced positive top-line results from a US Phase II, 24-week study for its subcutaneous depot formulations of small molecule GLP-1 receptor agonist ASC30 for obesity. The study achieved its primary endpoint, with patients receiving three doses of once-monthly ASC30 SC depot formulation A1 demonstrating a statistically significant and clinically meaningful placebo-adjusted mean weight loss of 6.3% at week 12.

All 65 participants enrolled in three cohorts using two formulations - A1 and A2 - were obese or overweight with at least one weight-related comorbidity. The subcutaneous version has shown efficacy as a monthly drug and may have potential as quarterly maintenance therapy.

In a separate development, Ascletis Pharma has selected ASC36, its first oral amylin receptor peptide agonist, for clinical development targeting obesity. The company plans to submit an Investigational New Drug application to the US FDA for ASC36 oral tablets. ASC36 uses Ascletis Pharma's Artificial Intelligence assisted drug discovery and proprietary oral delivery technology.

The company's stock has seen substantial gains, with the 1 year return at 246.6% and the 5 year return at 442.5%. The current share price stands at HK$16.6, with the stock up 44.1% year to date and 28.7% over the past month, despite a 1% decline over the past week. At HK$16.60, the share price sits about 23% below the HK$21.65 analyst target range midpoint.

The company remains loss making with a P/E of -60.22 and very small revenue.