CAMARILLO, Calif.--(BUSINESS WIRE)--REMD Biotherapeutics, Inc. (“REMD Bio”), together with its subsidiary, Beijing CoSci-REMD Bio (“Cosci‑REMD Bio”), today announced positive top-line results from a phase 2 clinical program of volagidemab (“Vola”) in patients with type 1 diabetes were presented at the American Diabetes Associations (ADA) 81st Scientific Sessions (ADA2021) as an oral presentation in the session entitled Novel Therapeutic Agents and Approaches.
The program enrolled a total of 153 patients at eleven clinical sites in the United States in two randomized, placebo-controlled, double-blind trials to evaluate the safety, efficacy and pharmacodynamics of a once-weekly injection of volagidemab at 35 mg and 70 mg for 12 weeks in patients with type 1 diabetes who are currently receiving insulin treatment.
Trial 2 results showed a statistically significant and clinically meaningful decrease in hemoglobin A1C and daily insulin use. In Trial 2, placebo-adjusted decrease in A1C was 0.53% and 0.49% and in patients with baseline A1C ≥7.5%, placebo-adjusted decrease in A1C was 0.89% and 0.51% for 35 mg and 70 mg volagidemab groups, respectively. In Trials 1 and 2 combined, there was a two-fold increase in the number of patients achieving Week 12 A1C of ≤7% in the volagidemab treatment arms versus placebo. No increases in hypoglycemia were observed with volagidemab treatment.
Jeremy H. Pettus, M.D., Associate Professor of Medicine, Division of Endocrinology at UCSD and a principal investigator on the study presented the results at the virtual ADA 2021 Conference. “I have long been an advocate for exploring adjunctive therapies to insulin in patients with type 1 diabetes, and the results of this trial suggest that Vola is the most potent adjunctive therapy studied to date in terms of improvements in glycemic control. Therapies that improve glucose control and avoid hypoglycemia represent an important unmet need in the treatment of type 1 diabetes,” said Dr. Pettus. “Phase 3 clinical studies in type 1 diabetes patients are unfortunately rare, so I’m excited to see this compound moving forward and for the potential to participate in a Phase 3 study of volagidemab in this disease.”
“Based on the results of this study, we are meeting with the FDA to discuss the design of the Phase 3 studies,” said Hai Yan, Ph.D., Chief Executive Officer at 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. REMD Bio’s lead product candidate, volagidemab (REMD-477), a fully human competitive antagonistic 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.