Melior Pharmaceuticals said that based upon results of its Phase 2 clinical study with Bukwang Pharmaceuticalds, a milestone has been achieved and as a result the partners will advance the compound into an additional Phase 2 clinical study. This event also triggers a success milestone to Melior.

The 4-week protocol enrolled 130 diabetic subjects across 19 clinical sites in the U.S. and Korea. Based on the safety and efficacy exhibited by MLR-1023, the partners are progressing the compound into a 12-week Phase 2b study with glycosylated hemoglobin A1c (HbA1c) levels as its primary endpoint.

“Naturally we are very pleased to be progressing our partnership with Bukwang based upon the outcome of this first Phase 2 study with MLR-1023,” said Andrew Reaume, chief executive officer, Melior. “We are proud to be partnered with one the most dynamic R&D-based Korean pharmaceutical companies.”

MLR-1023 is an oral insulin sensitizer in development for the treatment of type 2 diabetes. It 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 mechanisms. Preclinical studies show that MLR-1023 has the potential to lower blood glucose levels more effectively than existing therapies without the risk of hypoglycemia or weight gain. It improves beta-cell function in diabetes models and combines well with current anti-diabetic drugs including metformin. Melior expects MLR-1023 will be dosed once daily.