Date: 2016-11-10
Type of information: Results
phase: 3
Announcement: results
Company: Anthera Pharmaceuticals (USA - CA)
Product: blisibimod
Action
mechanism: fusion protein/peptibody. Blisibimod is a novel FC-fusion protein, or peptibody, and is distinct from an antibody. It is a selective inhibitor of B-cell activating factor (BAFF), to explore its clinical utility in various autoimmune diseases including systemic lupus erythematosus (SLE) and IgA nephropathy. BAFF is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. Abnormal elevations of B-cells and BAFF may lead to an overactive immune response, which can damage normal healthy tissues and organ systems.
Disease: systemic lupus erythematosus (SLE)
Therapeutic area: Autoimmune diseases
Country:
Trial details:
Latest
news: * On November 10, 2016, Anthera Pharmaceuticals announced that the CHABLIS-SC1 clinical trial with blisibimod for the treatment of systemic lupus erythematosus (SLE) failed to meet its primary endpoint based upon the SLE Responder Index-6 (SRI-6) at 52 weeks. Although 47% of patients in the blisibimod arm versus 42% of patients in the placebo arm achieved this endpoint, the difference was not statistically significant. The SRI is a composite index comprised of SELENA-SLEDAI, BILAG and Physician Global Assessment criteria. A SRI-6 response requires a decrease of at least 6 points in SELENA-SLEDAI. The magnitude of blisibimod treatment effects for other SLE Response (SRI-4, and SRI-8) also did not achieve statistical significance. Serum biological markers including B-cells, immunoglobulins, and complement demonstrated statistically significant treatment effects consistent with expectations and previous blisibimod clinical studies in lupus and IgA nephropathy. Adverse events between the blisibimod and placebo treatment arms were well balanced and blisibimod was generally well tolerated. Anthera Pharmaceuticals will continue to analyze the data in the coming weeks from the CHABLIS-SC1 trial in consultation with key lupus disease thought leaders to expeditiously determine the future of the blisibimod lupus program including the on-going CHABLIS 7.5 clinical study. As the pharmacological effects on immunological markers, such as B-cells and immunoglobulins, were as expected, the company is continuing the development of blisibimod for the treatment of IgA Nephropathy (IgAN) pending 48 week results from the ongoing phase 2 BRIGHT study. IgAN has a very different pathogenesis than systemic lupus, and the pharmacological activity of blisibimod might prove effective in its treatment. The Company expects to report 48-week data from the BRIGHT-SC IgAN study and topline data from the Sollpura™ SOLUTION phase 3 study later this year. * On February 10, 2015, Anthera Pharmaceuticals announced the successful completion of an interim analysis of its Phase 3 trial (CHABLIS-SC1) of blisibimod in patients with Systemic Lupus Erythematosus and that the study should continue to completion as planned. An independent statistician conducted the interim futility analysis for the CHABLIS-SC1 study, evaluating the SRI-6 response at the 24 week time point. Enrollment in the trial is projected to conclude in mid-2015. Prior to the interim analysis and in response to recent input from the Company's Scientific Advisory Board following the publication of clinical data from other Lupus studies with BAFF inhibitors, the Company modified the primary endpoint of CHABLIS-SC1 from SRI-8 response to SRI-6 response, which was previously a secondary endpoint of the study. SRI-8 will remain a key secondary endpoint of the study. The Systemic Lupus Erythematosus Response Index (SRI) is an approved endpoint recognized by the FDA for previously approved therapeutics. Anthera has also completed a Scientific Advice Process meeting with the European Medicines Agency (EMA) regarding the blisibimod development program for the treatment of IgA Nephropathy (IgAN). Earlier this quarter the Company obtained written feedback regarding the acceptability of a single pivotal study as the initial basis for a conditional market authorization application (MAA) in the European Union utilizing proteinuria as the primary endpoint. In addition, the EMA also provided recommendations to address treatment duration, durability of response and need for re-treatment in the BRIGHT-SC study. Anthera and its Japanese development partner Zenyaku Koygo Co., Ltd. plan to incorporate them in a protocol amendment prior to the planned interim analysis for the BRIGHT-SC study which will be completed later this quarter.
