EXTON, Pa.--(BUSINESS WIRE)--Melior Pharmaceuticals I, Inc. announced today that it has randomized the first patient into treatment arms of a Phase 2b study aimed at evaluating the efficacy of MLR-1023 in adults with uncontrolled Type 2 diabetes on metformin therapy. The 12-week treatment protocol will enroll 400 subjects across 61 clinical sites in the U.S. and Korea. The study is a joint development effort between Melior Pharmaceuticals I (USA) and Bukwang Pharmaceutical Company (Korea).
This study follows a positive Phase 2a proof-of-concept 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.
“Given the positive results we showed in our first study, we continue to expect MLR-1023 to represent a ground-breaking therapy as the first in a new class of insulin sensitizers that is not associated with the untoward effects of PPAR-active compounds,” said Andrew Reaume, CEO of Melior Pharmaceuticals I.
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-related interactions. 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 animal models of diabetes and combines well with current anti-diabetes drugs. Melior expects MLR-1023 will be dosed once daily.
Melior Discovery and its sister company, Melior Pharmaceuticals I, 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 oncology, gastrointestinal disorders, CNS disorders and metabolic diseases.