Human Genome and GSK Announce Positive Lupus Study Results

20 October 2009 (Last Updated October 20th, 2009 18:30)

Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) have announced positive results in a Phase III trial for Benlysta (belimumab), a new treatment for patients with debilitating and potentially fatal systemic lupus erythematosus. The data demonstrated that belimumab plus standard of car

Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) have announced positive results in a Phase III trial for Benlysta (belimumab), a new treatment for patients with debilitating and potentially fatal systemic lupus erythematosus.

The data demonstrated that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate when compared to placebo.

Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. If approved, the treatment would be the first new drug for lupus approved by regulatory authorities in more than 50 years.

GSK MD and senior vice-president of biopharm development Carlo Russo said that the company hoped to confirm the effectiveness demonstrated by belimumab in the BLISS-52 study in the second Phase III study, which is to report shortly.

"We very much hope that we will be able to deliver a new option for the treatment of this debilitating disease," Russo said.

Results from BLISS-76, the second Phase III trial of belimumab, will be announced on 2 November 2009. If the results from BLISS-76 are consistent with these findings, HGS and GSK will plan to submit marketing applications in the US, Europe and other regions in the first half of 2010.