Bukwang Pharm announced that it has completed the phase 2 pre-study with MLR-1023, a new treatment candidate substance for Type 2 diabetes, in cooperation with U.S.-based Melior Pharmaceuticals.
The Korean pharmaceutical company official said, “After we had approval of the phase 2 pre-clinical trial plan with MLR-1023 from the U.S. Food and Drug Administration (FDA) and Korean FTA, we have conducted a study at eight hospitals in the U.S. and 10 hospitals in Korea since the end of last year. In the future, we are planning to analyze the clinical trial results on the safety and efficacy of MLR-1023 by early next year, and start the phase 2 post clinical trials right away.”
He also added, “The diabetes drug market in South Korea is worth about 350 billion won (US$296.36 million), while its global market is a huge market exceeding US$25 billion (29.53 trillion won). For diabetes treatments, diabetes drugs with new mechanisms are currently leading the market. Therefore, once MLR-1023 with a totally different mechanism from existing diabetes drugs is successfully developed, it will have great effects on the existing diabetes treatment market as an innovative new drug.”
MLR-1023 improves glycemic control by directly and selectively activating the Lyn tyrosine kinase enzyme, which has been shown to modulate insulin-signaling pathways independently of PPAR-related interactions. Also, it is a new treatment candidate substance with a new mechanism that lowers blood glucose levels more effectively than existing therapies.