Bukwang Announces completion of dosing of MLR-1023’s phase 2b study.


Bukwang announced that it has completed the clinical trials of MLR-1023, a new diabetic drug candidate. This is a phase 2b clinical trial of 400 patients with type 2 diabetes mellitus at a total of 61 sites, including 40 sites in the US and 21 sites in Korea. On November 29, the last patient received the last dosing and study will be completed once 4 week observation period is over.

5 years since Bukwang signed license agreement, speed of development is quite fast when considering several long term toxicity studies are already completed, filed additional global patent and now global Phase 2b is soon to be completed.

The company is expected to overturn the biggest hurdle of new drug development through this phase 2b study, which enrolled 400 patients.

Phase 2a data, which was also presented in 76th ADA (American Diabetes Association), already showed significant reduction in both post- and fasting-glucose. Additionally, some group showed statistically significant weight loss.

Once MLR-1023 is launched, expected peak annual sales will be more than 3 trillion Korean Won (KRW). Current diabetes market is dominated by following new drug classes such as, DPP4 inhibitor, GLP1 agonist, SGLT-2 inhibitor. MLR-1023 is believed to be insulin sensitizer with MoA of Lyn Kinase activator, and because of its novelty and current circumstance of current market, we believe that our estimate is very reasonable.

Bukwang representative said "As MLR-1023 has reached the stage of completion of Phase 2b clinical trials, the expectation for the results is growing both internally and externally."


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