JW Pharmaceutical is seeking to advance Bofanglutide, an obesity treatment administered once every two weeks, into a Phase 3 clinical trial in South Korea. The company aims to halve the dosing frequency in the GLP-1 obesity treatment market, where once-weekly administration is currently the norm.
JW Pharmaceutical said Aug. 18 that it had submitted an investigational new drug application (IND) to South Korea’s Ministry of Food and Drug Safety for a Phase 3 trial of Bofanglutide, an obesity treatment candidate.
The trial will enroll 300 South Korean adults who are obese or overweight. The company plans to begin the trial in December and evaluate Bofanglutide’s weight-loss efficacy and safety compared with a placebo through March 2029.
Bofanglutide is a GLP-1 receptor agonist for which JW Pharmaceutical acquired exclusive development and commercialization rights in South Korea from China-based Gan & Lee Pharmaceuticals in April. By stimulating GLP-1 receptors, the drug promotes insulin secretion and slows the rate at which food leaves the stomach, helping maintain a feeling of fullness for longer. This suppresses appetite and promotes weight loss.
The drug’s biggest distinguishing feature is its dosing schedule. Unlike most widely used GLP-1 obesity treatments, which are administered once a week, Bofanglutide is being developed as a subcutaneous injection administered once every two weeks. If commercialized, it could reduce the number of annual injections from 52 to 26.
In April, JW Pharmaceutical signed a licensing agreement with Gan & Lee worth up to $81.1 million. Gan & Lee is conducting a separate Phase 3 trial, GRADUAL-3, in China to assess the potential for once-monthly administration of Bofanglutide.
An earlier Phase 3 trial in China, GRADUAL-1, demonstrated weight-loss efficacy. Among 640 adults who were obese or overweight and received treatment for 52 weeks, average body weight decreased by 15.12% in the 24-milligram group and 18.54% in the 48-milligram group from baseline. The placebo group recorded a 1.11% reduction.
In terms of safety, adverse events similar to those observed with existing GLP-1 treatments were reported. Most major gastrointestinal adverse events were mild or moderate, and no new safety signals were identified.
JW Pharmaceutical plans to expand Bofanglutide’s development beyond obesity into other metabolic diseases. The South Korean rights secured by the company also cover type 2 diabetes, obstructive sleep apnea (OSA) and metabolic dysfunction-associated steatohepatitis (MASH).
A JW Pharmaceutical official said, “We plan to clearly demonstrate Bofanglutide’s weight-loss efficacy and tolerability, which were confirmed in previous overseas clinical trials, in South Korean patients,” adding, “We will accelerate development to provide a new obesity treatment option with both clinical efficacy and dosing convenience.”