HAYWARD, CA, USA I August 03, 2016 I Anthera Pharmaceuticals, Inc. (ANTH) today announced that the last patient in the Phase 3 CHABLIS-SC1 clinical study, evaluating blisibimod for the treatment of systemic lupus erythematosus, received their final study dose on July 27th. As described in the protocol, patients are followed for eight weeks after their last dose at which time the final safety data is collected. Due to timing of this final visit, the company expects topline efficacy and safety data will be available prior to the annual American College of Rheumatology Annual Meeting in November.
“We are very pleased that we have had our last patient dosed in this 52-week active dosing study,” said James Pennington, MD, Anthera’s Interim Chief Medical Officer. “We continue to aggressively collect, analyze and finalize the CHABLIS-SC1 database as the final patients suffering from lupus complete the study. To date, the mean baseline SELENA-SLEDAI score, a measure of lupus disease activity, is 13.6 and in-line with our hypothesis of studying people with more severe disease.”
Topline data from the CHABLIS-SC1 will include the primary endpoint evaluation, a six-point reduction in the Systemic Lupus Erythematosus Responder Index (SRI-6) as well as safety and tolerability data from the study.
About CHABLIS-SC1
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 442 patients in 12 countries across Asia, Eastern Europe and Latin America. Patients received either 200mg of blisibimod or placebo in addition to their standard-of-care medication for 52 weeks. The primary endpoint of the CHABLIS-SC1 study will be clinical improvement in the SRI-6 response at 52 weeks. With 442 evaluable patients, the study is powered at 89% to detect a 14% treatment difference assuming a 25% placebo response rate. 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 study, please visit http://www.anthera.com/clinical-studies/chablis_sc/.
About Blisibimod
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 an anti-BAFF antibody. 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 two Phase 1 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.
SOURCE: Anthera Pharmaceuticals
Post Views: 439
HAYWARD, CA, USA I August 03, 2016 I Anthera Pharmaceuticals, Inc. (ANTH) today announced that the last patient in the Phase 3 CHABLIS-SC1 clinical study, evaluating blisibimod for the treatment of systemic lupus erythematosus, received their final study dose on July 27th. As described in the protocol, patients are followed for eight weeks after their last dose at which time the final safety data is collected. Due to timing of this final visit, the company expects topline efficacy and safety data will be available prior to the annual American College of Rheumatology Annual Meeting in November.
“We are very pleased that we have had our last patient dosed in this 52-week active dosing study,” said James Pennington, MD, Anthera’s Interim Chief Medical Officer. “We continue to aggressively collect, analyze and finalize the CHABLIS-SC1 database as the final patients suffering from lupus complete the study. To date, the mean baseline SELENA-SLEDAI score, a measure of lupus disease activity, is 13.6 and in-line with our hypothesis of studying people with more severe disease.”
Topline data from the CHABLIS-SC1 will include the primary endpoint evaluation, a six-point reduction in the Systemic Lupus Erythematosus Responder Index (SRI-6) as well as safety and tolerability data from the study.
About CHABLIS-SC1
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 442 patients in 12 countries across Asia, Eastern Europe and Latin America. Patients received either 200mg of blisibimod or placebo in addition to their standard-of-care medication for 52 weeks. The primary endpoint of the CHABLIS-SC1 study will be clinical improvement in the SRI-6 response at 52 weeks. With 442 evaluable patients, the study is powered at 89% to detect a 14% treatment difference assuming a 25% placebo response rate. 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 study, please visit http://www.anthera.com/clinical-studies/chablis_sc/.
About Blisibimod
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 an anti-BAFF antibody. 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 two Phase 1 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.
SOURCE: Anthera Pharmaceuticals
Post Views: 439
