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news.Monoclonal antibodies developer Immunomedics has begun patient dosing for two pivotal phase III clinical trials to further evaluate the safety and efficacy of the epratuzumab in with systemic lupus erythematosus.
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Epratuzumab has been designated by the FDA as a fast track product for the potential treatment of patients with moderate and severe systemic lupus erythematosus (SLE), known as lupus. Epratuzumab is a humanized monoclonal antibody that targets an antigen, known as CD22, found on the surface of a certain class of lymphocytes, a type of white blood cell.
The pivotal trials are randomized, double-blinded, placebo-controlled, multi-center studies using the BILAG (British Isles lupus assessment group) index to monitor and assess disease activity. A high BILAG score indicates increased disease activity. One trial, named ALLEVIATE A, is for patients with severe SLE flares, and the second trial, named ALLEVIATE B, is for patients with moderately active SLE.
“We are pleased to advance our lead drug candidate, epratuzumab, into pivotal phase III lupus trials, and to be at the forefront of lupus therapy research,” commented Dr Ivan Horak, executive vice president of R&D and chief scientific officer of Immunomedics.
Pharmaceutical Product Development Inc will work with Immunomedics to carry out the pivotal trials and discussions with potential partners for epratuzumab in all indications are ongoing.