Bukwang Pharm. announced today that MLR-1023 was dosed to the first patient in the clinical trial. With this, the multinational phase 2a clinical trial for the compound was initiated. MLR-1023 is a novel anti-diabetic agent currently under co-development with Melior Pharmaceuticals I.
Bukwang received IND approval for the clinical trial from the US FDA last July and Korea MFDS last September. Following this, IRB approval was sought from the respective hospitals and patients were recruited. First patient was enrolled on the 6th of December last year and started their wash-out and placebo run-in periods, and then was dosed with MLR-1023 for the first time today. “Our plan now is to complete dosing within this year, analyze the safety and efficacy data from the trial early next year and then start the phase 2b trial straight afterwards,” Bukwang’s representative said.
The anti-diabetic market is a huge market, its size estimated to be about 350 billion Korean Won (about 350 million USD, assuming 1000 Won/1 USD) in Korea and 25 billion USD worldwide. Treatments with new mechanisms of action are leading the market these days. “MLR-1023 is expected to make a large 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 the ongoing multinational clinical trial of apatinib mesylate (targeted anti-cancer agent) and the recent acquisition of Contera Pharma, a Danish bioventure company.