EXTON, Pa.--(BUSINESS WIRE)--Melior Pharmaceuticals, Inc. announced today that, based upon results of its Phase 2 clinical study with Bukwang, a significant milestone has been achieved. 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, CEO of 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.
Melior Discovery and Melior Pharmaceuticals, its sister company, are leaders in pharmaceutical drug repositioning using the unique theraTRACE® platform comprised of multiplexed in vivo disease models. Melior is using these capabilities to build an internal pipeline of development candidates and also partners with pharmaceutical and biopharmaceutical companies to apply the theraTRACE® platform and its in-depth in vivo pharmacology expertise to their development candidates. Melior Discovery and Melior Pharmaceuticals are privately held and located in Exton, PA. For more information, visit www.meliordiscovery.com.
About Bukwang Pharmaceutical Company, Ltd.
Bukwang Pharm. Co., Ltd. is a leading Korean pharmaceutical company listed on the Korean Stock Exchange [KRX:003000]. The company has been in business for over 50 years. Sales are primarily derived from products licensed from Europe, the United States and Japan. The company is currently investing significant resources in R&D to create a robust pipeline of preclinical and clinical agents for the treatment of antiviral diseases, gastrointestinal disorders, CNS disorders and metabolic diseases.