HAYWARD, Calif., June 16, 2015 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced that it has met the enrollment target of its CHABLIS-SC1 Phase 3 clinical trial evaluating blisibimod for the treatment of lupus. Final data from the trial is expected in the second half of 2016.
"Reaching our enrollment target for CHABLIS-SC1 ahead of schedule is an important accomplishment," said Dr. Colin Hislop, MD, Anthera's Chief Medical Officer. "The accelerated pace speaks to the importance of patient identification and selection in lupus treatment. In addition, the wealth of new information released over the past year regarding the treatment of Systemic Lupus Erythematosus (SLE) and BAFF inhibition has demonstrated that patients with more severe disease, such as those enrolled in the CHABLIS-SC1 trial, are more likely to respond to a BAFF therapy. We look forward to the culmination of our efforts in CHABLIS-SC1 next year as we continue the development of blisibimod."
Results from CHABLIS-SC1, and eventually CHABLIS-SC2, are anticipated to support marketing approval for blisibimod as a treatment for active SLE that is not controlled by current best practice standard-of-care, including corticosteroids.
Chablis-SC1 is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, tolerability and immunogenicity of blisibimod in patients with seropositive, clinically-active lupus (SELENA-SLEDAI ≥ 10) who require corticosteroid therapy in addition to standard-of-care for treatment of their disease. The study enrolled 400 patients in 15 countries across Asia, Eastern Europe and Latin America. Patients receive either 200mg of blisibimod or placebo in addition to their standard-of-care medication for 52 weeks. The primary endpoint of the CHABLIS-SC1 will be clinical improvement in the SRI-6 response at 52 weeks. Key secondary outcomes from the study, including SRI-8, reduction in the number of lupus flares and steroid use, are intended to further differentiate blisibimod from currently available therapies. For more information on the CHABLIS-SC1 trial, please visit https://clinicaltrials.gov/ct2/show/NCT01395745?term=chablis&rank=1.
Blisibimod is a selective peptibody antagonist of the B-cell activating factor (BAFF) cytokine that is initially being developed as a treatment for lupus. BAFF is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. It is primarily expressed by macrophages, monocytes and dendritic cells and interacts with three different receptors on B-cells including BAFF receptor, or BAFF-R, B-cell maturation, or BCMA, and transmembrane activator and cyclophilin ligand interactor, or TACI. The BAFF-R receptor is expressed primarily on peripheral B-cells. Blisibimod consists of a novel BAFF binding domain fused to the N-terminus of the Fc region of human antibody. Blisibimod binds to BAFF and inhibits the interaction of BAFF with its receptors. The role of BAFF in lupus has recently been clinically validated in multiple late-stage clinical studies with anti-BAFF antibodies. We intend to advance the development of our BAFF antagonist, blisibimod, to exploit its broad potential clinical utility in autoimmune diseases, with initial focus on lupus. Blisibimod demonstrates anti-BAFF activity and has been shown to be safe and effective in selectively modulating and reducing B-cells in Phase 1 and Phase 2 clinical studies in lupus patients.
About Anthera Pharmaceuticals, Inc.
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including lupus, lupus with glomerulonephritis, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis. Additional information on the Company can be found at www.anthera.com.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Quarterly Report on Form 10-Q for the year ended March 31, 2015. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Dennis Lutz of Anthera Pharmaceuticals, Inc. firstname.lastname@example.org or 510.856.5598Source:Anthera Pharmaceuticals, Inc.