Researchers from Human Genome Sciences have announced positive test results on their drug Benlysta to treat the debilitating and often deadly disease lupus.
Lupus is a complicated spectrum of autoimmune diseases that afflicts an approximated 1.5 million Americans and 5 million people globally, the large majority of them women between age 15 and 45. It gets its name from the Latin word for wolf because, in 1851, a doctor saw a patient with red marks on her face that looked like wolf bites. Lupus has not had a new drug approved to treat it in more than 20 years.
Researchers from Human Genome Sciences say the experimental drug Benlysta has drastically cut lupus symptoms in a randomized trial of approximately 850 patients, lowering their need for debilitating steroids and improving quality of life.
For the study, 57.6 percent of patients taking a high dose of Benlysta demonstrated a statistically substantial improvement, compared to 43.6 percent of patients who were given a placebo. Of patients taking a low dose, 51.7 percent showed improvement. The drug was usually well tolerated. The study is the first of two late-stage clinical trials requested by the U.S. FDA. The second study is scheduled to take place in November. HGS, which developed the drug with GlaxoSmithKline, is hoping for FDA approval by early 2010.
Moreover, the 865 patients in the 52-week study â€” which was carried out at 90 locations in 13 countries, primarily in Asia, South America and Eastern Europe â€” were able to cut their use of Prednisone, a steroid treatment generally used by lupus patients. Benlysta stops the action of a naturally occurring protein needed in the development of certain B cells, part of the immune system, that produce antibodies believed to play a significant role in lupus and other autoimmune diseases.
The Rockville-based firm’s stock rose past $10 and closed at $12.51, up $9.19, or 277 percent. Some analysts have predicted that the company’s stock could pass $15 if the drug is approved.
Benlysta has one final late-stage trial to finish before the FDA will approve it. The results are to be reported in November, with approval pending for 2010. If the trials are successful, Benlysta can be available for widespread lupus treatment by 2011.