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JW Pharmaceutical is launching a domestic Phase 3 trial of Bofanglutide, an obesity treatment given once every two weeks. The drug halves the number of doses compared with existing once-weekly glucagon-like peptide-1 (GLP-1) treatments, aiming to improve patient convenience
The company said on the 18th that it had filed an investigational new drug (IND) application for the Phase 3 trial with the Ministry of Food and Drug Safety. The multicenter, placebo-controlled Phase 3 trial will enroll 300 domestic adults with obesity or overweight. Pending approval from the ministry, the company plans to begin the trial in December and to evaluate weight-loss efficacy and safety against placebo through March 2029
Bofanglutide is a GLP-1 receptor agonist for which JW Pharmaceutical secured exclusive domestic development and commercialization rights in April from China’s Gan & Lee Pharmaceuticals. It acts on GLP-1 receptors in the pancreas to stimulate insulin secretion and slows the emptying of food from the stomach to increase satiety, thereby suppressing appetite and driving weight loss
Unlike the once-weekly GLP-1 obesity treatments now in wide use, it is being developed as a subcutaneous (SC) injection given once every two weeks. Cutting the annual number of doses from 52 to 26 is expected to improve convenience and medication adherence
According to earlier Phase 3 results in China, Bofanglutide reduced body weight from baseline by 15.12% in the 24-mg dose group and by 18.54% in the 48-mg dose group after 52 weeks of treatment. JW Pharmaceutical said it plans to verify in Korean patients the efficacy and tolerability confirmed in the overseas trial
The company also plans to pursue Phase 3 trials for additional indications of Bofanglutide in sequence, starting with obesity, to expand its portfolio of original prescription drugs in the metabolic disease field
A JW Pharmaceutical official stressed, “We will clearly demonstrate in Korean patients the weight-loss effect and tolerability confirmed in overseas trials,” adding, “We will accelerate development so that we can offer a new obesity treatment option that combines clinical efficacy and dosing convenience.”
#JWPharmaceutical#Bofanglutide#ObesityDrug#GLP1#WeightLoss#Phase3
Original reporting by Lee Yeon-soo for Seoul Economic Daily
AI-translated from Korean. Quotes from foreignxact original wording
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