Benlysta Remains Front-Runner in LE
Ocrelizumab may remain a viable candidate for MS treatment, given the precedent for serious infection as an acceptable risk in this patient population. But for LE, a chronic autoimmune disorder affecting more than 1.5 million Americans, mostly women of childbearing age, the antibody candidate to beat may be Human Genome Sciences (HGS) and GlaxoSmithKline’s (GSK) Benlysta. Given that the mAb is already in Phase III, if successful, the treatment will become the first new therapy approved for LE in about 50 years.
In November 2009, HGS and GSK announced that the antibody met the primary endpoint in BLISS-76, the second of two Phase III trials in seropositive LE (SLE). Study results through 52 weeks showed that Benlysta 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate compared with placebo plus standard of care.
In addition to reduced lupus symptoms, patients noted fewer flare-ups, less fatigue, better quality of life, and an ability to decrease typical steroid dose. The study also showed that the antibody was generally well tolerated, with rates of overall adverse events and infections as well as discontinuations due to adverse events comparable between both treatment arms.
Upon news of the successful clinical trial results, Leerink Swann research analyst Joseph P. Schwartz reaffirmed an Outperform rating for HGS, saying that he expected Benlysta to gain regulatory approval and then reach the market by the second half of 2010. He boosted his fair value outlook for the stock to $40 from $30 and expects the company to present full results from BLISS-76 at an upcoming medical conference.
Ocrelizumab may be out of the game in LE, but for Biogen Idec, with its significant franchise in MS, positive results with Benlysta really matter. Roche and Biogen Idec are thus continuing with one clinical trial testing Ocrelizumab in MS.
The most advanced results from the drug in this indication came last December. The companies reported that the antibody produced significant reductions in signs of disease activity among 220 treatment-naïve and previously treated patients with the relapsing-remitting form. The aim is to get a potentially safer but equally effective drug as Tysabri, which will extend Biogen Idec’s MS franchise.