MacroGenics, Inc. (5036640, a Maryland-based biotechnology company) and the world’s leading charitable funder of type 1 diabetes research – Juvenile Diabetes Research Foundation (JDRF) – have formed a partnership in order to support a pivotal multinational Phase II/III clinical trial of teplizumab (MGA031).
MGA031 is MacroGenics’ proprietary compound that has shown promise in slowing the progression of type 1 diabetes in children and adults newly diagnosed with the disease.
The "Protege" trial will test teplizumab, an anti-CD3 humanized monoclonal antibody capable of suspending the autoimmune attack that destroys insulin producing beta cells in people with recent-onset type 1 diabetes.
Additionally, JDRF also will fund research at Yale University conducted by Dr. Kevan Herold to analyze biological samples from the Protege trial with the goal of further elucidating the mechanism of action of teplizumab.
The Protege trial will assess the effectiveness, tolerance, and safety of teplizumab in three different dosing regimens in children and adults with recent-onset type 1 diabetes. The trial is designed to assess teplizumab's capacity to reduce insulin requirements, while maintaining relatively normal blood sugar levels.
Depending on specific milestones in the trial, JDRF will provide up to $2 million in funding.
Find more details from the press release.
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