HGS, GSK Report Positive Phase 3 Results For Benlysta

Human Genome (HGS) and GlaxoSmithKline (GSK) has reported that Benlysta (belimumab) met its primary endpoint by achieving a significant improvement in patient response rate versus placebo in BLISS-52. BLISS-52 is the first of two pivotal phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE).

Belimumab met its primary efficacy endpoint of superiority versus placebo on week 52.

Repotedly, a clinically and statistically significant improvement was shown in patient response rate for belimumab plus standard of care vs placebo plus standard of care, 57.6% for 10mg/kg belimumab, 51.7% for 1mg/kg belimumab and 43.6% for placebo.

Carlo Russo, senior vice president of Biopharm Development at GSK, said: “Benlysta is the medicine being developed specifically for lupus that has reached this late stage of clinical development with positive results. We look forward to completing the pivotal studies, with the hope of bringing this potentially important therapeutic advance to patients suffering from SLE.