EXTON, Pa.--(BUSINESS WIRE)--Melior Pharmaceuticals I, Inc. is pleased to announce that it has randomized the last patient into its Phase 2b study for subjects with uncontrolled Type 2 diabetes on metformin therapy. The 12-week treatment protocol enrolled a total of 433 subjects across 61 clinical sites in the U.S. and Korea. The study is a joint development program between Melior Pharmaceuticals I (USA) and its Asian development partner, Bukwang Pharmaceutical Company (Korea).
This study follows a positive Phase 2a proof-of-concept (POC) study that the partners completed last year in which statistically significant glucose lowering was achieved for both glucose parameters (fasting plasma glucose and area-under-the curve in a mixed meal tolerance test). In addition, positive trends were seen in lipid parameters and body weight in that 4-week study.
“Following the positive results that we observed in our previous clinical study, and our emerging understanding for the role played by Lyn kinase in insulin sensitivity, induction of lipolysis, and beta cell protection, we have confidence in the outcome of the existing study,” said Andrew Reaume, President & CEO of Melior Pharmaceuticals I, Inc.
Tolimidone (MLR-1023) is a first-in-class Lyn kinase activator that serves as a dual non-PPAR insulin sensitizer and modulator of lipid metabolism which is in development for the treatment of Type 2 diabetes. In addition to the positive effect on glucose, lipids and weight observed in the recent clinical POC study, improvement of in beta cell function has been characterized in animal models of diabetes.
Increasing understanding for the role of Lyn kinase activation has led Melior to explore development of tolimidone in other disease areas with significant unmet needs. Nonalcoholic steatohepatitis (NASH) is the most advanced of these programs. Melior expects to initiate clinical development in NASH in early 2019.
Melior has partnered with Bukwang Pharmaceutical Company for the rights to develop and commercialize in Type 2 diabetes in the Asia region, excluding Japan, and is currently exploring global partnering opportunities with other parties in the US, EU, and Japan.
Melior Pharmaceuticals is developing a pipeline of de-risked therapies in areas with significant unmet needs, including diabetes, NASH, Parkinson’s disease and sleep disorders. The company leverages the proprietary drug-repositioning technology of its affiliate company, Melior Discovery, to identify new targets and indications for drug candidates that have already undergone clinical studies in other indications. Melior Pharmaceuticals and Melior Discovery are privately held and located in Exton, PA. For more information, visit www.meliorpharma.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 oncology, gastrointestinal disorders, CNS disorders and metabolic diseases.