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.

“The results from this study will increase our understanding of the mechanisms that cause high blood sugar.”

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.”

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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.