- 400 patient enrollment in 61 sites (US & KR)
Bukwang Pharmaceutical Co., Ltd. announced completion of global Phase 2b study of anti-diabetic agent, MLR-1023, that currently under co-development with Melior Pharmaceutical I. Inc.
This global phase 2b targeted 400 type 2 diabetes patients in both US and Korea with 61 sites. Since the first patient randomized in September 2017, study completed enrollment within 11 months. Accordingly, study is expected to be completed by end of this year and be able to obtain result in early 2019.
MLR-1023 was developing as global new drug in both US and Korea, and successfully completed global phase 2a. Its positive results including significant reduction in PPG (postprandial plasma glucose) and FPG (fasting plasma glucose), and significant reduction in weight in some selected population, was introduced and highlighted in American Diabetes Association.
Newly introduced class of drug is dominating the current diabetes market, such as DDP4 inhibitor, GLP1 agonist, and SGLT2 inhibitors.MLR-1023, first-in-class drug that works directly on insulin sensitivity via activating Lyn kinase, would yield the maximum of 3B USD annual sales in total global market of 31B USD.
Bukwang representative said, “Through the new drug development including MLR-1023, our company is planning to further devote our efforts to find the company’s future growth engine by advancing into global market.”