REMD Biotherapeutics Completes Enrollment and Announces Top-line Results of a Phase 2 Clinical Study of Volagidemab (REMD-477) in Patients with Type 1 Diabetes
CAMARILLO, Calif.--(BUSINESS WIRE)--REMD Biotherapeutics, Inc. (“REMD Bio”), together with its subsidiary, Beijing CoSci-REMD Bio Med-Tech Co, Ltd (“Cosci-REMD Bio”), today announced they have completed enrollment and have top-line results in a phase 2 study of volagidemab (REMD-477) in patients with type 1 diabetes. The study, which enrolled approximately 150 patients at eleven clinical sites in the United States, is a randomized, placebo-controlled, double-blind study to evaluate the safety, efficacy, and pharmacodynamics of volagidemab at 35 mg and 70 mg in patients with type 1 diabetes who are currently receiving insulin treatment. The study consisted of two parts: Part A with unblinded continuous glucose monitoring (CGM) and inpatient stays and Part B with blinded CGM and no inpatient stays.
“The study demonstrated that, compared to placebo, volagidemab treatment was associated with meaningful improvements in glycemic control as measured by hemoglobin A1C and CGM parameters in type 1 diabetes patients after 12 weeks of treatment,” said Dung “Zung” Thai M.D., Ph.D., Chief Medical Officer at REMD Bio. “At this time, we are only announcing the top-line results as we are hoping to present the detailed study results at an upcoming scientific conference.”
“We are very pleased to have completed enrollment and have results of this study ahead of schedule. We believe volagidemab could be an add-on therapy for the nearly 70 percent of people with type 1 diabetes whose blood-sugar levels are not controlled by insulin alone and we plan to build on the results of this study to advance this program to serve the unmet medical needs of these patients,” added Hai Yan, Ph.D., President, co-founder, and CEO of REMD Bio and Cosci-REMD Bio.
About Type 1 Diabetes
Type 1 diabetes typically results from the autoimmune destruction of the insulin-producing β-cells in the pancreas. The subsequent lack of insulin leads to hyperglycemia and glycosuria. Presently, the primary therapy for type 1 diabetes is insulin; there is no cure and no means of prevention. According to the Juvenile Diabetes Research Foundation, approximately 1.6 million Americans are living with type 1 diabetes and 64,000 more people are diagnosed each year in the U.S. In addition, fewer than one-third of people with type 1 diabetes in the U.S. consistently achieve target blood-glucose control.
About REMD Biotherapeutics
REMD Biotherapeutics is a privately held, clinical-stage biotechnology company focused on creating and developing innovative protein-based therapies to treat metabolic diseases and other serious illnesses. The Company was founded by two former Amgen research scientists and has facilities in Camarillo, California and Beijing, China (Beijing CoSci-REMD Bio Med-Tech Co, Ltd). REMD Bio’s lead product candidate, volagidemab (REMD-477), a fully human antibody to the glucagon receptor licensed from Amgen in 2013, is presently in clinical studies for treatment of diabetes as well as in preclinical studies for treatment of other metabolic disorders. REMD Bio’s discovery research leverages extensive expertise in generating and developing therapeutic antibodies to G protein-coupled receptors (GPCRs) as well as to other multi-transmembrane cell surface antigens.
More information can be found at www.remdbio.com.
Dung “Zung” Thai