Therapy Areas: Diabetes
REMD Biotherapeutics Completes Enrollment, Posts Top-line Results of a Phase 2 Clinical Study of Volagidemab (REMD-477) in Patients with Type 1 Diabetes
7 January 2021 - - US- and China-based biotechnology company REMD Biotherapeutics, Inc, together with its subsidiary, Beijing CoSci-REMD Bio Med-Tech Co, Ltd, has completed enrollment and have top-line results in a phase 2 study of volagidemab (REMD-477) in patients with type 1 diabetes, the company said.

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 and inpatient stays and Part B with blinded CGM and no inpatient stays.

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 1.6m Americans are living with type 1 diabetes and 64,000 more people are diagnosed each year in the US.

In addition, fewer than one-third of people with type 1 diabetes in the US consistently achieve target blood-glucose control.

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.