GlaxoSmithKline (LSE: GSK) announced that it has reached the US Food and Drug Administration’s (FDA) targeted primary efficacy endpoint in the second and final phase 3 trial of its lupus drug treatment, BENLYSTA. The ‘Bliss-76’ trial the drug achieved a statistically significant improvement in patient response rates.
The initial result of the ‘pivotal’ trial represents a key milestone in the drug’s development, GSK intend to submit marketing applications in the first half of 2010, following discussions with regulatory authorities in the United States, Europe and other regions.
Systemic Lupus Erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders.
In August 2006, Human Genome Sciences (Naqdaq: HGSI) and GSK entered into a definitive co-development and co-commercialisation agreement under which HGS took responsibility for conducting the Benylsta Phase 3 trials, with assistance from GSK. Going forward the companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.
In total the Phase 3 study, is the largest clinical trial programme ever conducted in lupus patients. BLISS-52 randomised and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76 randomised and treated 819 patients at 136 clinical sites in 19 countries, primarily in North America and Europe.
The BLISS-76 study is ongoing and will continue for 24 more weeks. Belimumab (Benlysta) is the first in a new class of drugs called BLyS-specific inhibitors. The drug met the indentified end-point in both studies and as such complied with the FDA specified Special Protocol Assessment Agreement.
Carlo Russo, MD and Senior Vice President of GSK’s Biopharm Development division commented on the trial success: “The results from this second pivotal Phase 3 trial reinforce our belief that belimumab could deliver a significant therapeutic option for patients with lupus who have had no new treatment in 50 years. We look forward to continuing our collaboration with HGS in order to bring this important medicine to patients."