Human Genome Sciences to begin phase 3 program for lupus drug LymphoStat-B this year

By E. Janene Geiss

Philadelphia, Aug. 9 - Human Genome Sciences, Inc. said Wednesday that its phase 3 clinical development program for LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus is slated to begin this year.

"Advancing LymphoStat-B to phase 3 development is a critically important step in the evolution of Human Genome Sciences into a commercial organization," H. Thomas Watkins, president and chief executive officer, said in a company news release.

Human Genome said it designed the phase 3 program in collaboration with GlaxoSmithKline and leading international lupus experts, and expects to begin phase 3 trials of LymphoStat-B before the end of 2006.

The company said it has met with both the Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products and has received agreement on the major components of the phase 3 program, including the primary efficacy endpoint, target patient population and dose selection.

Human Genome said it plans to submit the final LymphoStat-B phase 3 protocols to the FDA soon for a Special Protocol Assessment.

The phase 2 results show that LymphoStat-B, as measured by this combined response rate, significantly reduced disease activity in serologically active patients, officials said.

As proposed by the company, the phase 3 development program for LymphoStat-B will include two double-blind, placebo-controlled, multi-center phase 3 superiority trials that will evaluate the efficacy and safety of LymphoStat-B plus standard of care, versus a placebo plus standard of care, in the treatment of patients with active lupus.

The primary efficacy endpoint of both studies is the patient response rate at week 52, as defined by a reduction from baseline in the Selena Sledai score of at least four points, no worsening in Physician's Global Assessment, no new Bilag A organ domain score and no more than 1 new Bilag B organ domain score from baseline, officials said.

The total duration of the two studies will differ at 76 weeks and 52 weeks, respectively.

Aside from duration, the two studies will have similar protocols, officials said.

In each trial, about 810 patients will be enrolled and randomized to one of three treatment groups.

Patients will be dosed intravenously on days zero, 14 and 28, then every 28 days.

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 through 52.

Safety and tolerability will be evaluated by an independent data monitoring committee throughout both studies.

In July 2005, GlaxoSmithKline exercised its option under a June 1996 agreement to co-develop and co-commercialize LymphoStat-B with Human Genome throughout the world.

The companies said they have now entered into a definitive co-development and co-commercialization agreement under which Human Genome will have responsibility for conducting the LymphoStat-B phase 3 trials with assistance from GlaxoSmithKline.

Human Genome said it will receive a $24 million payment from GlaxoSmithKline in the third quarter of 2006, in consideration of GlaxoSmithKline's right to co-develop and co-commercialize LymphoStat-B.

The companies said they will share equally in phase 3/ 4 development costs, sales and marketing expenses, and profits of any product commercialized under the agreement.

LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BlyS. It is a Human Genome Sciences drug, created through a collaboration with Cambridge Antibody Technology. It has received a fast-track product designation from the FDA for its potential use in treating lupus and has been selected for participation in the FDA's continuous marketing application pilot 2 program.

Human Genome Sciences is a Rockville, Md., biopharmaceutical company.

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