Bukwang Pharmaceuticals Co., Ltd. (Bukwang) announced that it has submitted to MFDS an IND for conducting Phase 2b clinical trial for MLR-1023, which is a new drug candidate for Type 2 Diabetes treatment.
MLR-1023 is currently being joint-developed by Bukwang Pharmaceuticals Co., Ltd and Melior Pharmaceuticals I, Inc for Type 2 Diabetes treatment. The repositioned drug’s new mechanism of action improves glycemic control by direct and selective activation of Lyn kinase enzyme. In multinational Phase 2a clinical study, MLR-1023 demonstrated glucose lowering effect in mixed meal tolerance test (MMTT), which was the primary endpoint, and data was presented in 76th American Diabetes Association (ADA).
The Phase 2b study design is based on the outcome of previous study, clinical guideline, as well as consultation with experts in diabetes. The study is expected to be initiated in March 2017, involving approximately 60 clinical sites in both United States and Korea.
The Phase 2b study is going to enroll subjects with a diagnosis of Type 2 Diabetes who are not adequately controlled by metformin treatment. Primary objective of the study is to assess efficacy of HbA1c in 12 weeks of treatment of MLR-1023 in combination with metformin.
Bukwang representative mentioned that “Conducting Phase 2b study will allow us to step forward in developing new anti-diabetic drug with new mechanism of action, and with current preclinical and previous clinical study’s result, we are expecting to successfully complete the study.”