JW Pharmaceutical will enter phase 3 clinical trials in Korea for the obesity drug candidate administered once every two weeks, "Bofanglutide."
JW Pharmaceutical said on the 18th that it applied to the Ministery of Food and Drug Safety for a domestic phase 3 clinical trial plan (IND) for Bofanglutide.
The trial is a multicenter, placebo-controlled study of 300 adult patients in Korea with obesity or overweight. JW Pharmaceutical plans to start the trial in Dec. and evaluate Bofanglutide's weight-loss effect and safety through Mar. 2029.
Bofanglutide induces weight loss by stimulating glucagon-like peptide (GLP)-1 receptors in the pancreas to promote insulin secretion and delay gastric emptying, increasing satiety.
In Apr., the company secured exclusive rights in Korea to develop and commercialize Bofanglutide from Gan & Lee Pharmaceuticals.
Notably, unlike the once-weekly dosing commonly used in the current obesity drug market, Bofanglutide is being developed for subcutaneous injection once every two weeks.
If approved, the annual number of doses could be cut roughly in half, from 52 to 26, which the company expects will improve patients' dosing convenience and treatment persistence.
Prior trials in China also confirmed weight-loss effects. In the phase 3 "GRADUAL-1" study conducted in China, after 52 weeks of Bofanglutide, the 24 mg group saw a 15.12% reduction in body weight from baseline, and the 48 mg group saw an 18.54% reduction. The company said the study confirmed efficacy and tolerability.
JW Pharmaceutical plans to expand development of Bofanglutide beyond the obesity indication to other metabolic disease indications as well. Through this, it aims to strengthen its portfolio of prescription drugs in the metabolic disease field.
A company official said, "We plan to clearly prove in domestic patients the weight-loss effect and tolerability of Bofanglutide confirmed in previous overseas trials," and added, "We will accelerate development to offer a new obesity treatment option with clinical efficacy and dosing convenience."