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news.MacroGenics has said that its lead product candidate, MGA031, an anti-CD3 monoclonal antibody, has received orphan drug designation from the FDA for treatment of type 1 diabetes.
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MacroGenics is planning to initiate a phase II/3 trial to study MGA031 in patients with recent-onset type 1 diabetes in the fourth quarter of 2006.
“In previous clinical trials, this anti-CD3 monoclonal antibody was shown to interfere with the autoimmune mechanism underlying type 1 diabetes, potentially slowing its progression, and therefore improving the health and quality of life of patients with diabetes,” said Scott Koenig, President and CEO, MacroGenics.
“We also believe that MGA031 may have applicability in other autoimmune diseases, including psoriatic arthritis and multiple sclerosis,” he continued.
Orphan drug designation is a status given to products for rare diseases or conditions. The designation qualifies MacroGenics for exclusive marketing rights in the US for seven years if the company is first to receive marketing approval for an anti-CD3 monoclonal antibody of the same sequence for the indication.