JW Pharmaceutical has announced its initiation of a Phase 3 clinical trial for its obesity treatment candidate, Bopanglutide, which is administered once every two weeks.
The company submitted the Investigational New Drug (IND) application for Bopanglutide to the Ministry of Food and Drug Safety on August 18. The trial will involve 300 adult participants in South Korea who are obese or overweight. The company plans to start the trial in December and evaluate the efficacy and safety of Bopanglutide compared to a placebo group until March 2029.
Bopanglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist for which JW Pharmaceutical secured exclusive development and commercialization rights in South Korea from China’s Gan & Lee Pharmaceuticals in April. The drug works by stimulating insulin secretion and delaying gastric emptying through the pancreatic GLP-1 receptor, promoting satiety and reducing appetite, leading to weight loss.
Unlike existing GLP-1 obesity treatments that require weekly injections, Bopanglutide is being developed as a subcutaneous injection administered every two weeks. This reduces the annual injection frequency from 52 to 26, potentially improving patient adherence and convenience.
In a previous Phase 3 trial conducted in China (GRADUAL-1), significant weight loss effects and tolerability were confirmed, with a 15.12% reduction in weight for the 24 mg group and an 18.54% reduction for the 48 mg group after 52 weeks of treatment.
JW Pharmaceutical plans to sequentially pursue additional Phase 3 trials for other indications beyond obesity to expand its portfolio of original prescription drugs in the metabolic disease field.
A company representative stated, "We plan to demonstrate the excellent weight loss effects and tolerability of Bopanglutide, confirmed in previous overseas trials, in domestic patients as well. We will accelerate development to provide a new obesity treatment option that combines clinical efficacy and convenience of administration."
Previously, the company signed an exclusive licensing agreement for Bopanglutide with Gan & Lee, with a total contract value of $81.1 million. The agreement includes milestones for the development, approval, and sales of four indications: type 2 diabetes, obesity, obstructive sleep apnea (OSA), and metabolic dysfunction-associated steatotic liver disease (MASH). Royalty payments will be made separately based on a percentage defined by sales brackets.
* This article has been translated by AI.
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