Ascletis Reveals Breakthrough Phase Ib Results for ASC47 Weight Loss Drug in the US and Australia

Ascletis Pharma's Promising Phase Ib Findings for ASC47

In a pivotal announcement, Ascletis Pharma Inc. has shared positive topline results from the Phase Ib studies of its innovative weight loss drug candidate, ASC47. Conducted in Australia and involving participants with elevated low-density lipoprotein cholesterol (LDL-C) and obesity, these findings indicate a significant leap forward in obesity treatment embodied by ASC47’s unique therapeutic profile.

ASC47 is designed as an adipose-targeted, muscle-preserving drug candidate that aims to combat obesity effectively while helping maintain muscle mass. Results from the single subcutaneous injection studies revealed a remarkable drug half-life of 26 days in healthy subjects and 40 days in patients with obesity, paving the way for potential administration on a monthly to bimonthly basis.

The Phase Ib trials demonstrated that ASC47 was both safe and well-tolerated among participants, with no reports of serious adverse events. Preliminary efficacy data displayed promising trends in weight loss over a specified period, which is particularly noteworthy when considering ASC47’s mechanism of action. The drug operates through UCP-1-mediated thermogenesis that facilitates weight reduction while preserving muscle, a benefit not commonly seen with other incretin-based drugs.

Initial weight loss results from ASC47 injections exhibited a compelling placebo-adjusted mean weight loss peak of 1.7% by day 50, which is indicative of the potential effectiveness of this treatment. In the context of previous preclinical studies, the data suggests that ASC47, when used in conjunction with semaglutide, demonstrated a significant 56.7% greater reduction in body weight compared to using semaglutide alone. This highlights ASC47’s promising role as a powerful adjunct therapy for obesity treatment.

Moreover, notable reductions in LDL-C (up to 22%) and total cholesterol (up to 16%) were observed, reiterating the drug's potential beyond weight loss—pointing towards an active engagement with cholesterol metabolism in humans.

With the U.S. Food and Drug Administration (FDA) recently clearing the Investigational New Drug (IND) application for ASC47 in combination with semaglutide, Ascletis is poised to initiate further research into this combination therapy. The upcoming clinical study will involve diverse cohorts of patients suffering from obesity, and the results from the single doses of ASC47 when combined with semaglutide will play a key role in supporting future research.

CEO Jinzi Jason Wu expressed excitement about these developments, confirming both the clinical potential of ASC47 and the company's commitment to advancing it as a monotherapy and combination treatment for obesity.

In conclusion, the encouraging results from the Phase Ib studies not only illuminate the path for ASC47’s future as a treatment option for obesity but also shape the prospective treatment landscape. With ongoing developments expected in the latter half of 2025, stakeholders and patients alike will be keenly watching the progress of ASC47 at Ascletis.