Melior Pharmaceuticals I, Inc (Melior) and Bukwang Pharmaceuticals Co., Ltd. (Bukwang) announced today that they have achieved positive results in their Phase 2a proof-of –concept study to evaluate MLR-1023 in patients with Type 2 diabetes. The study met its primary endpoint (lowering of post-prandial plasma glucose as evaluated in a mixed meal tolerance test) as well as several secondary endpoints including the lowering of fasting plasma glucose at a statistically significant level as per protocol design. The study also revealed positive effects towards lipid levels and body weight. The results were presented on June 12th at the 76th Sessions of the American Diabetes Association in New Orleans, LA.
The 4-week clinical study, conducted by both Bukwang and its partner, Melior, enrolled 130 subjects across 19 clinical sites in the USA and Korea.
Key highlights of the results include:
Statistically significant reduction in area-under-the-curve (AUC) in a mixed meal tolerance test was achieved at the low dose (100mg) both in the once-daily treatment group (QD) and twice-daily treatment group (BID). MMTT reduction in QD was -86.49 mg*hr/dL and BID group was -91.53 mg*hr/dL when compared to placebo treated group.
Statistically significant reduction of fasting plasma glucose (FPG) was achieved after 28 days of treatment in the 100mg; -38.5 mg/dL.
At the most effective doses for glucose lowering, statistically significant lowering of body weight was observed in the US subject ; -0.58kg.
The treatment was generally well-tolerated.
Dr. William T. Cefalu, Professor at Louisiana State University’s Pennington Biomedical Research Center, the editor-in-chief of Diabetes Care and associate editor for Diabetes with the American Diabetes Association, who was an investigator on this study mentioned that “The MLR-1023 compound, by showing a reduction of glucose and favorable effects on weight in the early phase studies, may address unmet clinical needs and warrants further evaluation in Phase II studies.”
MLR-1023 is an oral insulin signal potentiating agent in development for the treatment of Type 2 diabetes. It improves glycemic control by directly and selectively activating the Lyn kinase enzyme, which has been shown to modulate insulin-signaling pathways independently of PPAR-related interactions. Preclinical studies showed that MLR-1023 has the potential to lower glucose levels more effectively than existing therapies while also lowering weight without altering food intake.