Along with its subsidiary Cosci-REMD Biotherapeutics, US firm REMD Biotherapeutics has received US FDA approval to begin a trial of its lead product candidate, REMD-477, in patients with type 1 diabetes.
The company intends to initiate the Phase Ib trial in January 2016.
The trial is designed to evaluate the safety, tolerability, and pharmacodynamics of REMD-477 following a single dose in insulin-treated patients with type 1 diabetes.
Washington University School of Medicine Center for Human Nutrition director Samuel Klein said: “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.”
20 patients will be enroled in the trial at Washington University School of Medicine in St. Louis and at UC San Diego School of Medicine.
REMD Bio and Cosci-REMD Bio president, co-founder and CEO Hai Yan said: “This Phase Ib 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 II clinical study in type 2 diabetes in September, we are excited to expand our clinical scope with this study in type 1 diabetes.”
The company noted that in preclinical studies, REMD-477 corrected hyperglycemia within a week of treatment, and restored normal levels of HbA1c in rodent models of type 1 diabetes after chronic treatment.