In This Article:
-Ultra-long-acting subcutaneous (SQ) injection formulation of small molecule ASC30 demonstrated a 36-day half-life in patients with obesity, supporting once monthly or less frequent administration.
-As previously disclosed, oral tablet formulation of small molecule ASC30 demonstrated potentially best-in-class 6.3% weight loss in patients with obesity after a four-week treatment.
HONG KONG, March 31, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") today announces positive interim results from its randomized, double-blind, placebo-controlled Phase Ib single subcutaneous (SQ) injection study (NCT06679959), conducted in the U.S., of small molecule ASC30 with three ultra-long-acting SQ injection formulations in patients with obesity (body mass index (BMI): 30-40 kg/m2).
The Phase Ib study investigated the half-life of three ultra-long-acting SQ injection formulations of ASC30 (100 mg, single injection), a small molecule GLP-1 receptor (GLP-1R) agonist, developed from Ascletis' ultra-long-acting platform (ULAP). In each cohort, eight patients received one formulation of ASC30 SQ injection and two patients were on volume-matched placebo.
One of the evaluated three formulations demonstrated a 36-day half-life in patients with obesity after a single SQ injection, supporting once monthly or less frequent administration. In addition, this formulation is a sterile solution for SQ injection and stable around neutral pH, allowing for potential co-formulation and co-administration with other drugs or drug candidates. This formulation of small molecule ASC30 SQ injection is advancing into further clinical trials to evaluate clinical efficacy at doses above 100 mg.
The other two formulations, which have different chemical and physical properties from the formulation mentioned above, also demonstrated ultra-long-acting potential in patients with obesity.
As previously disclosed, the oral tablet formulation of small molecule ASC30 demonstrated potentially best-in-class 6.3% weight loss in patients with obesity after a four-week treatment (Press Release).
ASC30 SQ injection was generally well tolerated, demonstrating a favorable safety profile in the Phase Ib study. No serious adverse events (SAEs) were reported. There were no Grade 3 or higher adverse events (AEs) observed. The majority of gastrointestinal (GI)-related AEs were mild (Grade 1). There were no elevations of liver enzymes including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBL). There were no abnormal findings in laboratory tests, vital signs, ECGs (electrocardiograms, including QTc intervals), and physical exams. Most injection site reactions of ASC30 were mild. There were no Grade 3 or higher injection site reactions.