JW Pharmaceutical(001060) said on the 28th that it applied to the Ministery of Food and Drug Safety for an investigational new drug (IND) application for a phase 3 clinical trial to treat type 2 diabetes with the drug candidate "Bofanglutide."
The phase 3 trial will enroll 174 adults in Korea with type 2 diabetes whose blood sugar is not adequately controlled despite combination therapy with metformin and an SGLT-2 inhibitor. JW Pharmaceutical plans to begin the trial in Jan. next year and evaluate the efficacy and safety of the Bofanglutide combination group versus placebo through Feb. 2029.
Bofanglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist drug candidate that JW Pharmaceutical in Apr. licensed in from Gan & Lee Pharmaceuticals of China. JW Pharmaceutical secured exclusive rights in Korea for development and commercialization of the molecule.
Bofanglutide activates GLP-1 receptors in the pancreas to promote insulin secretion and control blood sugar. It also delays gastric emptying, and is being developed as a therapy for metabolic diseases such as obesity and type 2 diabetes.
In particular, unlike existing GLP-1 therapies dosed once weekly, it is being developed as a subcutaneous injection administered once every two weeks. Reducing annual injections from 52 to 26 is expected to lessen the treatment burden for diabetes patients who need long-term therapy and improve medication convenience.
JW Pharmaceutical plans to use this phase 3 push to strengthen its metabolic disease new drug pipeline spanning obesity and diabetes.
A JW Pharmaceutical official said, "This phase 3 trial is a procedure to objectively verify the efficacy and safety of Bofanglutide in patients with type 2 diabetes whose blood sugar is not controlled with existing combination therapy," adding, "We will proceed with the trial without delays to strengthen our metabolic disease portfolio that spans obesity and diabetes and provide patients with a new treatment option that improves convenience."