BOSTON, Nov. 2 (Reuters) - Human Genome Sciences Inc said on Monday its experimental lupus drug was successful in a late-stage clinical trial, paving the way for approval of the first treatment for the autoimmune disease in 50 years.
Results of the trial, which were announced early on Monday, showed patients who took a high dose of the drug, Benlysta, experienced a statistically significant improvement in symptoms compared with those taking a placebo.
The result met the main goal of the trial.
The positive results from the trial are expected to be a big boost for Human Genome, which will share profits from Benlysta on a 50-50 basis with partner GlaxoSmithKline Plc.
Some analysts estimated the drug will be worth as much a $3 billion a year -- nice for Glaxo, the world's No. 2 drugmaker, and transformational for Human Genome, a small Rockville, Maryland-based company that has struggled in the shadows for years.
Data showed that after 52 weeks, 46.9 percent of patients taking 10 milligrams per kilogram of Benlysta plus the current standard of care, experienced an improvement in symptoms as measured by scale known as Selena Sledai.
That compared with 35.6 percent of patients taking standard of care plus a placebo.
The trial also measured patients who took a low dose of the drug. The results of that part of the trial were not statistically significant.
Serious side effects were reported in 26.8 percent of patients taking Benlysta, compared with 24 percent of patients taking a placebo.
Lupus is a complex autoimmune disease that causes the immune system to attack the body's own tissue and organs, including the joints, kidneys, heart, lungs, brain, blood and skin. It can cause arthritis, kidney damage, chest pain and skin rash, among other disorders.
The trial, known as BLISS-76, is the second of two required by the U.S. Food and Drug Administration in order for the drug to be considered for approval. Human Genome GlaxoSmithKline said they plan to file for approval in the first quarter of next year.
The results follow similarly successful data from a trial known as BLISS-52 that were released in July. That trial showed that 57.6 percent of patients taking a high dose of Benlysta showed an improvement in symptoms compared with 43.6 percent of patients taking the placebo.
Lupus affects about 1.5 million people in the United States and 5 million worldwide, according to the Lupus Foundation of America.
Benlysta, which is given once a month by IV infusion, is designed to inhibit BLyS, a naturally occurring protein in the body that exists to keep B-cells functioning normally. B-cells make antibodies that prevent infection. In patients with lupus, B-cells are overstimulated and produce antibodies that attack the body.
(Editing by Lincoln Feast) Keywords: HUMAN GENOME/ (toni.clarke@thomsonreuters.com; 617-856-4340; reuters messaging: toni.clarke.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
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