Glaxo, Human Genome: Benlysta Meets Late-Stage Trial Endpoint

17th Jun 2010 10:33

LONDON (Dow Jones)--GlaxoSmithKline Plc (GSK) and U.S.-based partner Human Genome Sciences Inc. (HGSI) Thursday said their jointly-developed experimental drug Benlysta met its primary endpoint in a late-stage clinical study, further boosting its potential to become the first new treatment in 50 years for the hard-to-treat autoimmune disease lupus. The results on Benlysta, also known as belimumab, will be presented Thursday in Rome at the 2010 Congress of the European League Against Rheumatism (EULAR). "The BLISS-76 Phase 3 results presented at EULAR extend the findings of previous studies and reinforce our belief that belimumab, assuming regulatory approval, could deliver a significant therapeutic option for seropositive patients with systemic lupus," David Stump, Human Genome Sciences Executive Vice President of Research and Development said in a statement. "In both of its pivotal Phase 3 trials in these patients, belimumab 10 mg/kg met its primary endpoint. The efficacy of treatment with belimumab plus standard of care, compared with placebo plus standard of care, was superior in both studies, with overall adverse event rates for belimumab comparable to placebo." Carlo Russo, GlaxoSmithKline's senior vice president in charge of biopharm development, said: "The BLISS-76 results presented at EULAR, taken together with the results of BLISS-52, reinforce our belief that belimumab may play an important role for patients living with lupus." Benlysta is not approved or licensed anywhere in the world. Earlier this month, they applied for U.S. regulatory approval for the experimental treatment after filing earlier in June to Europe's drug regulator for marketing approval there. -By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; [email protected] (END) Dow Jones Newswires June 17, 2010 05:33 ET (09:33 GMT)