Anthera Announces the Phase 2b PEARL-SC Data Has Been Accepted as a Late Breaking Poster Presentation at the ACR/ARHP 2012 Annual Scientific Meeting
HAYWARD, Calif., Nov. 1, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced that an abstract of the results from the Phase 2b PEARL-SC clinical study examining the treatment effect of blisibimod in systemic lupus erythematosus patients has been accepted as a late-breaking poster presentation at the 2012 Annual Scientific Meeting of the American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP).
"We are pleased to have this opportunity to share the PEARLS-SC responder analyses and sub-population results with the rheumatology community," said Colin Hislop, MD, Anthera's Senior Vice President and Chief Medical Officer. "In PEARL-SC, blisibimod demonstrated a clinically meaningful treatment effect in patients with severe disease who continued to have active lupus despite corticosteroid use. This highlights blisibimod's potential to help patients with more active and severe disease as we move forward with our Phase 3 clinical trials."
The poster entitled, "Blisibimod, an Inhibitor of B Cell Activating Factor, in Patients with Moderate-to-Severe Systemic Lupus Erythematosus," is scheduled to be presented by Dr. Richard Furie on Tuesday, November 13, from 9 am – 11 am Eastern Time (Presentation Number L6).
The abstract is available online through the ACR website at www.rheumatology.org. In accordance with the conference's embargo policy, the poster will be uploaded to the Anthera website only after completion of the session.
About Blisibimod and PEARL-SC
BAFF has been associated with a wide range of B-cell-mediated autoimmune diseases, including systemic lupus erythematosus, vasculitis, IgA nephropathy, immune thrombocytopenic purpura 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. The PEARL-SC Phase 2 study was designed as a randomized, double-blind, placebo-controlled, dose-ranging superiority trial to evaluate the safety, tolerability and efficacy of blisibimod plus standard of care, versus placebo plus standard of care. A total of 547 patients with active SLE were randomized to receive one of three different doses of blisibimod or placebo (100 mg weekly, 200 mg weekly or 200 mg monthly) administered subcutaneously over a minimum 24-week treatment period, in addition to standard-of-care therapy. The study was conducted at multiple centers worldwide.
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.
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 Annual Report on Form 10-K for the year ended December 31, 2011 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2012. 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: Bianca Nery of Anthera Pharmaceuticals, Inc., firstname.lastname@example.org or 510.856.5586.
SOURCE Anthera Pharmaceuticals, Inc.