Bukwang completes Phase IIa clinical trial for novel anti-diabetic candidate “MLR-1023”

Bukwang Pharmaceutical Co., Ltd. announced completion of Phase IIa of “MLR-1023”. MLR-1023 is a novel anti-diabetic agent currently under co-development with Melior Pharmaceuticals I, Inc.

At the end of last year, Bukwang initiated the trial in 8 sites in the US and 10 sites in Korea upon receipt of IND approval from the US FDA and Korea MFDS (Ministry of Food and Drug Safety). “Our plan now is to complete efficacy and safety analysis of MLR-1023 early next year, and then initiate Phase IIb study,” Bukwang’s representative said.

The anti-diabetic market is huge, estimated to be worth about 350 billion KRW (~350 million USD), and 25 billion USD worldwide. Treatments with new mechanisms of action have recently risen to lead the market. “MLR-1023 is expected to make a significant influence on the market when it is successfully developed, since it also has a new mode of action that is distinguished from those of currently used anti-diabetic treatments,” Bukwang’s representative said.

MLR-1023 is a new drug candidate that selectively activates Lyn kinase which is involved in insulin signaling. Activation of this kinase phosphorylates IRS-1,2 and ultimately lowers the blood glucose level.

Bukwang has passion and high hopes for innovative drug development to target the global market. Reflecting them are ongoing multinational clinical trials of apatinib mesylate (anti-cancer), and JM-010 (Levodopa-induced dyskinesia), and enhancing its capability on new drug development by scouting a lot of experts in Research and Development.

Bukwang’s representative added, “We are going to focus on finding growth engine for the company in the overseas market by innovative drug development, steering away from reliance on domestic market.”

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