HGS unveils proposed phase III program for LymphoStat-B

Human Genome Sciences (HGS) designed the phase III program in collaboration with GlaxoSmithKline and leading international systemic lupus erythematosus (SLE) experts, and expects to initiate phase III trials of LymphoStat-B (belimumab) before the end of 2006.

HGS has met with both the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA), and has received agreement on the major components of the phase III program, including the primary efficacy endpoint, target patient population, and dose selection. HGS plans to submit the final LymphoStat-B phase III protocols to FDA soon for a special protocol assessment (SPA).

As proposed by HGS, the phase III development program for LymphoStat-B will include two double-blind, placebo-controlled, multi-center phase III superiority trials that will evaluate the efficacy and safety of LymphoStat-B plus standard of care, versus placebo plus standard of care, in the treatment of patients with active SLE. The primary efficacy endpoint of both studies is the patient response rate at week 52.

Important secondary endpoints will include the patient response rate at week 76, the SF-36 Health Survey physical component summary score, fatigue measures, and the percentage of patients with reduction from baseline in average prednisone dose at weeks 40 to 52. Safety and tolerability will be evaluated by an independent data monitoring committee throughout both studies.

“It has been nearly forty years since a new drug has been approved by the FDA for lupus,” said Sandra Raymond, president and CEO of the Lupus Foundation of America. “We will be following the LymphoStat-B phase III clinical trials with great interest, both because of the significant unmet medical need that exists and because LymphoStat-B is being studied as a treatment for the underlying disease of lupus, rather than for the treatment of individual symptoms.”