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.