Yesterday, Anthera Pharmaceuticals, a biopharmaceutical company specializing in the development of drugs for treating serious diseases related to inflammation and autoimmune disorders, announced the final set of clinical data from its phase 2b PEARL-SC study in patients with systemic lupus erythematosus.
The final data from the study with 200mg weekly blisibimod suggests sustained and greater treatment effects versus placebo utilizing 6-, 7-, and 8-point improvements in the SELENA-SLEDAI disease-scoring index. In the predefined population of patients that had severe disease and were also taking corticosteroids, the SRI-8 treatment benefit in the 200mg weekly blisibimod cohort was seen as early as week eight and achieved statistical significance beginning at week 16 (35.4% blisibimod response as opposed to 17% placebo response, p=0.04) through the 24-week endpoint (41.7% blisibimod response versus 10.4% placebo response, p<0.001).
Also positive were supplementary data regarding time to first severe flare, total flares, proteinuria, and patients achieving a steroid dose reduction of below 7.5mg per day. Among subjects treated with 200mg of blisibimod each week, the mean time to first severe flare was 1.6-fold longer than subjects treated with placebo (348 days compared with 223 days). The reduction in proteinuria at week 24 was substantially greater among subjects treated with blisibimod as compared to placebo (35.0% versus 5.1%, p=0.045). Additional data from this recent analysis can be found at anthera.com. The full data from the PEARL-SC study will be presented at an upcoming scientific conference.
On June 28, Anthera Pharmaceuticals announced that the 200mg weekly subcutaneous dose of blisibimod showed a strong trend in improved clinical response in the modified intent to treat population as early as week 16 (p=0.14), the 24-week primary endpoint (p=0.15), and throughout week 44, including a statistically significant improvement at week 20 versus placebo (p=0.02). In addition, for patients that are severely ill and have seropositive lupus, defined as SELENA-SLEDAI>10 and receiving background corticosteroid medication, a more pronounced effect was seen in the 200mg weekly dose group, demonstrating a 13.8% treatment difference as compared to placebo at 24 weeks.
Anthera is advancing its development of blisibimod, which is a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. BAFF has been associated with a broad range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, vasculitis, IgA nephropathy, immune thrombocytopenic purpura, and others. Various clinical studies with other BAFF antagonists have recently reported on BAFF's potential positive role in treating lupus and rheumatoid arthritis.
Blisibimod is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns the global rights to blisibimod in all potential indications. The PEARL-SC phase 2 study was created as a randomized, double-blind, placebo-controlled, dose-ranging superiority trial for evaluating the safety, tolerability, and efficacy of blisibimod plus standard of care. In total, 547 patients with active SLE were randomized to receive one of three doses of blisibimod or placebo (100mg weekly, 200mg weekly or 200mg monthly), which was administered subcutaneously over a minimum 24-week treatment period in addition to standard-of-care-therapy. The study was conducted at multiple centers throughout the world.
Anthera Pharmaceuticals is a biopharmaceutical company specializing in the development and commercialization of products to treat serious diseases associated with inflammation and autoimmune diseases. For more information, visit the company's Web site at anthera.com
Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net