Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
- Category: Antibodies
- Published on Thursday, 26 April 2012 20:51
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HAYWARD, CA, USA I April 25, 2012 I Anthera Pharmaceuticals, Inc. (ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced the completion of dosing in the Company's Phase 2b PEARL-SC study. PEARL-SC (A randomized, double-blind Phase 2b study to evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus) is examining the therapeutic benefit of monthly and weekly subcutaneous administration of blisibimod in systemic lupus erythematosus (SLE) patients.
The primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in an SLE responder index (SRI)-- a composite responder index evaluating various patient and physician reported clinical disease activity including a SELENA/SLEDAI* improvement of 5 points or greater, no increase in a physician's global assessment of more than 0.3 points, with no new BILAG A or two or more new BILAG B organ domain scores.
In addition to the primary endpoint analysis, PEARL-SC will provide a series of key secondary subgroup and endpoint analyses which will help guide the design of phase 3 registration studies and further differentiate blisibimod from currently available therapies. These prospective secondary and exploratory analyses include:
Larger improvement in disease activity, as measured by SELENA/SLEDAI reductions of 5, 6, 7 and 8;
The percentage of patients achieving the primary endpoint and requiring no increase in steroid dose from baseline;
Percentage of patients able to reduce steroid dose and percentage of patients requiring no increase in steroid dose;
Time to first SLE flare and first severe SLE flare;
Disease activity improvement in lupus patients with higher levels of baseline disease receiving steroid treatment and meeting a more stringent biomarker threshold.
The PEARL-SC study remains on track and the Company plans to announce top-line data in the second quarter of 2012.
*SELENA/SLEDAI -- Safety of Estrogen in Lupus Erythematosus National Assessment / Systemic Lupus Erythematosus Activity Index is a cumulative, weighted index of systemic lupus erythematosus disease activity
About B-Cell Activating Factor (BAFF) and blisibimod
BAFF has been associated with a wide range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren's Syndrome, Graves' Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF's potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation and autoimmune diseases.
SOURCE: Anthera Pharmaceuticals