Camarillo, CA - REMD Biotherapeutics, Inc. (“REMD Bio”), together with its subsidiary, Beijing-based Cosci-REMD Biotherapeutics (“Cosci-REMD Bio”), today announced that the U.S. Food and Drug Administration (FDA) has approved the planned clinical study of the Company’s lead product candidate, REMD-477, in patients with type 1 diabetes. REMD Bio is poised to initiate this clinical study in January 2016.
“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. 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 Samuel Klein, M.D., William H. Danforth Professor of Medicine and Nutritional Science and Director of the Center for Human Nutrition at Washington University School of Medicine, and a principal investigator on the study.
The study is a phase 1b, double-blind, placebo-controlled, randomized study to evaluate the safety, tolerability, and pharmacodynamics of REMD-477 following a single dose in insulin-treated patients with type 1 diabetes. The study is expected to enroll a total of 20 patients at Washington University School of Medicine in St. Louis and at U.C. San Diego School of Medicine.
“This phase 1b clinical study builds on the promising preclinical data reported in PNAS 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,” stated Hai Yan, Ph.D., President, co-founder, and CEO of REMD Bio and Cosci-REMD Bio.
“The initiation of this clinical study is another important milestone for REMD Bio and Cosci-REMD Bio. We are pleased with the quick response from FDA, who reviewed and approved our IND in a month,” stated Hai Yan, Ph.D., President, co-founder, and CEO of the Companies.
About the PNAS Publication
As reported in the Proceedings of National Academy of Sciences (PNAS) earlier this year, in preclinical studies REMD-477 completely corrected hyperglycemia within one week after treatment and restored normal levels of HbA1c (a marker of prolonged diabetes control) in rodent models of type 1 diabetes after chronic treatment. The research reported in the PNAS article was performed by REMD Bio and a team at the University of Texas Southwestern Medical Center in Dallas led by Roger Unger, M.D., Professor and Touchstone/West Distinguished Chair in Diabetes Research. [Wang MY, et al., PNAS. 2015; 112(8): 2503-8.]
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