Lupus drug shows surprise phase III success
pharmafile | July 23, 2009 | News story | Research and Development, Sales and Marketing | Benlysta, GSK, HGS, Lupus
GSK and Human Genome Sciences’ lupus drug Benlysta has surprised analysts by showing unexpectedly positive results in a pivotal late-stage trial.
In a phase III trial Benlysta (belimumab) demonstrated a statistically significant improvement in symptoms in patients with serologically active systemic lupus erythematosus (SLE) compared to those taking a placebo.
The results of the trial took investors by surprise, many of whom had sold their shares in Human Genome Sciences (HGS) meaning they believed the drug would fail.
H Thomas Watkins, president and chief executive at HGS, said: “Benlysta has the potential to become the first new approved drug in decades for patients with systemic lupus. Given the limited treatment options currently available, patients would benefit greatly from potential new treatments.”
There were low odds on the trial being a success after results from an earlier trial were disappointing and because of the low success rate in the therapy area.
Other recent late-stage lupus trials that have failed include Biogen Idec and Roche’s Rituxan.
It has been more than 50 years since the last new drug for lupus was approved.
An analyst told Reuters: “This is a classic event in biotech. You have a disease that’s difficult to treat, nothing’s ever worked and you have a unique scenario in that the trial was actually successful.”
Investors who held onto their shares in HGC saw a huge return of 1,200%.
First in class
Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease and one of a number of forms of lupus, which affects around five million people worldwide.
About 90% of patients with lupus are women, and the disease is more common in young people aged 15-45, and in Black, Asian and Hispanic populations. Symptoms include extreme fatigue, painful and swollen joints, fever, skin rash and kidney problems.
Investigational monoclonal antibody Benlysta is being co-developed by HGS and GSK as part of a partnering deal struck in 2006.
The drug is the first in a new class of drugs called BLyS-specific inhibitors.
In lupus and some other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own health tissues. The presence of autoantibodies appears to be linked to the severity of the disease.
In the latest trial 51.7% of patients who took a low dose of the drug showed improvement in their symptoms and the results suggested that Benlysta can reduce autoantibody levels in SLE.
A second phase III trial is currently taking place to confirm these findings. Results are expected in November and the companies said if these are positive the drug will be submitted for marketing authorisation in the first half of 2010.
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