April 19, 2024

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[THE INVESTOR] Bukwang Pharmaceutical said on Aug. 7 that it has completed patient enrollment for phase 2b clinical trials of its type 2 diabetes drug candidate MLR-1023.

The drug maker said it expects to wrap up the clinical program involving 400 patients at 61 research sites in the US and Korea by the end of 2018. Key data from the studies will be unveiled early next year. 

“We will put more efforts in our overseas business expansion through the development of new drugs including MLR-1023,” the company said.

MLR-1023, co-developed by Bukwang and US-based Melior Pharmaceuticals, is an oral insulin signal potentiating agent, which is designed to lower blood glucose levels by activating the Lyn kinase that controls insulin signaling pathways.

The new study follows positive phase 2a clinical trials that were completed in 2016, with the results showing a reduction of glucose and favorable effects on weight.

The company is pinning hopes on MLR-1023 becoming a first-in-class drug as a Lyn kinase activator used in treating diabetes. The potential therapy is expected to generate up to 3 trillion won (US$2.66 billion) in sales a year to take a significant share of the global anti-diabetic treatment market, which is worth some US$31 billion.

Originally evaluated for the treatment of inflammatory bowel disorders, Melior and its partner Pfizer had terminated clinical trials due to lack of efficacy in the original indication.

After Melior explored the agent’s potential utility as a diabetes therapy, Bukwang licensed MLR-1023 for development and commercialization in Asian countries excluding Japan in 2013.

By Park Han-na (hnpark@heraldcorp.com)