Asceletis’ subcutaneous therapy, ASC47, was able to remain active in patients with elevated low-density lipoprotein cholesterol. Credit: Shutterstock / DimaBerlin.
Ascletis Pharma’s Phase Ib trial examining its adipose-targeted muscle-preserving weight loss candidate has been able to show a half-life of up to 26 days and 40 days in volunteers with high cholesterol and patients with obesity, respectively.
The Hong Kong-based company’s subcutaneous therapy, ASC47, was able to remain active in patients with elevated low-density lipoprotein cholesterol (LDL-C) following a single injection. Now, the company claims the trial results support a monthly or twice-monthly dosing regimen of the selective small molecule agonist.
The trial was run in two parts, the first was a single ascending dose (SAD) study involving the subjects with high LDL-C, split into three cohorts receiving 10mg, 30mg or 90mg of ASC47. In the second part, patients with obesity received a single 90mg dose or a placebo.
The single-site trial (NCT06427590) recruited 60 Australian volunteers with either high cholesterol for the first part, or obesity for the second. The study’s primary endpoint sought to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the weight loss therapy.
Both cohorts showed clinically significant placebo-adjusted mean reductions in LDL-C of up to 22% and total cholesterol (TC) of up to 16%.
In the obesity cohort, the trial found early signs that the treatment prompted minor weight loss. There was a placebo-adjusted mean weight loss of 0.2% at day 29, and 1.0% by day 43, peaking at 1.7% at day 50.
The company has said that its weight loss therapy is designed to reduce weight slowly whilst reducing the rate of muscle wastage inherent to the process. The drug is an adipose-targeted, once-monthly subcutaneous THRβ selective small molecule agonist.
A multiple ascending dose (MAD) study of ASC47 monotherapy for the treatment of obesity is expected to be initiated in the second half of 2025.
It follows after the company was awarded an Investigational New Drug (IND) application for ASC47 in combination with Novo Nordisk’s semaglutide for the treatment of obesity, by the US Food and Drug Administration (FDA). The first patient in this study is due to be dosed by the end of Q2 2025.
Jinzi Jason Wu, CEO of Ascletis, said: “We are excited and encouraged by the data from the ASC47 monotherapy Phase Ib studies in Australia in subjects with and without obesity and by the US IND clearance by the FDA for ASC47 in combination with semaglutide.”
“These data and FDA clearance increase our confidence that ASC47-based monotherapy and combination therapies have clinical potential to reduce body weight and preserve muscle compared to using incretin-based drugs alone. We are advancing the development of ASC47 as both a monotherapy and a combination therapy for the treatment of obesity and other metabolic diseases,” Wu added.
The announcement also follows after the company’s oral small molecule glucagon-like peptide 1 receptor agonist (GLP-1RA) was able to cut body weight by 6.3% after a 28-day Phase Ib trial.
Elsewhere, Bloom Science’s trial examining its primary pipeline weight loss drug, designed to replicate the positive effects of the ketogenic diet, has seen 80% of patients sustaining weight loss for two weeks after the last dose.
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