REMD Biotherapeutics, Inc., along with its Beijing-based subsidiary Cosci-REMD Biotherapeutics, recently announced that the U.S. Food and Drug Administration has approved the company’s clinical study to assess its drug candidate REMD-477 in patients with type 1 diabetes.
REMD-477 is a human antibody against the glucagon receptor, antagonizing its activity. Glucagon is a peptide hormone produced by the pancreas that can raise blood glucose levels, having an opposite action to insulin, which lowers glucose levels.
“Insulin is the primary therapy for patients with type 1 diabetes. Unfortunately, insulin often does not provide optimal blood sugar control, and many patients experience large fluctuations in blood sugar levels, including life-threatening hypoglycemia,” said Dr. Samuel Klein, a principal study investigator and the William H. Danforth Professor of Medicine and Nutritional Science and director of the Center for Human Nutrition at Washington University School of Medicine, in a press release.
REMD Bio will assess the safety, tolerability, and pharmacodynamics of REMD-477 in a randomized double-blind, placebo-controlled, Phase 1b study in patients with type 1 diabetes treated with insulin. The company expects to initiate the study in January 2016, enrolling 20 patients at U.C. San Diego School of Medicine and Washington University School of Medicine in St. Louis, Missouri.
“The current trial will evaluate the ability of REMD-477, which blocks the action of glucagon (a hormone that increases blood sugar), on blood sugar control and insulin requirements in patients with type 1 diabetes. The results from this study will increase our understanding of the mechanisms that cause high blood sugar in patients with type 1 diabetes, and could lead to a paradigm shift in the medical management of this disease,” said Dr. Klein.
“This phase 1b clinical study builds on the promising preclinical data reported in PNAS [Proceedings of National Academy of Sciences journal] earlier this year and is a step toward proof-of-concept for REMD-477 for the treatment of type 1 diabetes. After having just initiated a phase 2 clinical study in type 2 diabetes in September, we are excited to expand our clinical scope with this study in type 1 diabetes,” added Dr. Hai Yan, president, co-founder, and CEO of REMD Bio and Cosci-REMD Bio.
The PNAS article previously showed that REMD-477 was able to completely amend hyperglycemia and restore normal HbA1c levels (a marker of prolonged diabetes control) after a one-week treatment in type 1 diabetes rodent models.
REMD Biotherapeutics is a biotechnology company headquartered in Camarillo, California, working to develop antibodies and protein-based therapies for the treatment of metabolic diseases and other serious disorders.