REMD Biotherapeutics doses first Type 1 Diabetes patient with REMD-477

The randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, phyarmacodynamics, and glucose and insulin dose-lowering properties of REMD-477 in up to 20 patients with type 1 diabetes administered a single subcutaneous injection will enroll at Washington University School of Medicine in St. Louis and at U.C. San Diego (UCSD) School of Medicine.

"While insulin is a primary treatment for type 1 diabetes, exogenous insulin treatment may not be completely effective at controlling the disease, and hypoglycemia is a major and sometimes life-threatening side effect of insulin therapy, and a daily fact of life, for people with this disease. An additive therapy that can reduce daily insulin doses and reduce hyperglycemia may substantially reduce complications, and improve diabetic control and quality of life for type 1 diabetic patients," stated Robert R. Henry, M.D., Professor of Medicine at UCSD, Chief of the Center for Metabolic Research at the Veterans Affairs Healthcare System in San Diego, and Former President, American Diabetes Association, National Science & Medicine and Western Region.

"Glucagon is a hormone that works in concert with insulin to maintain glucose levels, yet therapy for type 1 diabetes has focused almost exclusively on insulin replacement. I believe failure to address glucagon dysregulation in type 1 diabetes represents a major missed opportunity in the current treatment approach. We hope the results of this study of REMD-477, an antibody that blocks the glucagon receptor, will confirm the role of glucagon as a major cause of hyperglycemia in type 1 diabetes," added Jeremy H. Pettus, M.D., Assistant Professor, Division of Endocrinology at UCSD and a principal investigator on the study.

"Recently research has been directed at the glucagon pathway as a therapeutic target, including developing antagonists of glucagon or glucagon receptor. The current trial will evaluate the safety and ability of REMD-477 to control blood sugar and its impact on the 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 changes in the medical management of this disease," added 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.

Hai Yan, Ph.D., President, co-founder, and CEO of REMD Bio and CoSci-REMD Bio, said: "This phase 1b study is building on results of the extensive studies in multiple rodent type 1 diabetes models with glucagon receptor antibody and the first-in-human clinical study of REMD-477 performed by Amgen in healthy volunteers in which there were no significant drug-related adverse events and there appeared to be a dose-dependent decline in glucose levels.

"Dosing the first patient with type 1 diabetes is another milestone for the Company in the development of REMD-477 for additional indications beyond our ongoing clinical trial in type 2 diabetes."

About Type 1 Diabetes

In people with type 1 diabetes, the body does not make enough insulin. The suppression of glucagon secretion by insulin in islets is lost. The disease usually starts in childhood, but can develop at any age. Presently the primary therapy for type 1 diabetes is insulin; there is no cure and no means of prevention.

According to the American Diabetes Association (ADA) approximately 1.25 million American children and adults have type 1 diabetes, and more than 18,000 youth are diagnosed each year with type 1 diabetes.