China-based Ascletis Pharma Inc. (HKG: 1672) announced positive topline results from a Phase Ib clinical study of its ASC47 in Australia. This adipose-targeted drug candidate, developed in-house, is designed to achieve weight loss without losing muscle mass.
Clinical Study Results
In the study, ASC47 demonstrated a half-life of up to 26 days in healthy subjects with elevated LDL-C and up to 40 days in patients with obesity following a single subcutaneous injection. These results support once-monthly to once-bimonthly administration. Additionally, ASC47 showed dose-proportional drug exposures (AUC) and Cmax values, with similar drug exposures observed between healthy subjects and patients with obesity.
IND Approval and Combination Study
The US FDA recently approved an Investigational New Drug (IND) filing for ASC47 in combination with semaglutide for obesity treatment. The combination study will include three cohorts of patients with obesity (BMI ≥ 30 kg/m²). Each cohort will receive a single low dose of ASC47 and four doses of semaglutide (0.5 mg, once weekly), with the first patient expected to be dosed by the end of the second quarter of 2025.
ASC47 Mechanism
ASC47 is an ultra-long-acting subcutaneously injected THRβ selective small molecule agonist. It possesses unique properties that enable adipose targeting, resulting in dose-dependent high drug concentrations in adipose tissue.-Fineline Info & Tech
Leave a Reply