Anthera Announces Additional Data from the Phase 2b PEARL-SC Presented at the
ACR/ARHP 2012 Annual Scientific Meeting
HAYWARD, Calif., Nov. 13, 2012
HAYWARD, Calif., Nov. 13, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc.
(Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious
diseases associated with inflammation and autoimmune disorders, today
announced additional data from its Phase 2b PEARL-SC study presented in a late
breaking poster at the 2012 Annual Scientific Meeting of the American College
of Rheumatology and the Association of Rheumatology Health Professionals
(ACR/ARHP). The poster entitled "Blisibimod, an Inhibitor of B cell Activating
Factor, in Patients with Moderate-to-Severe Systemic Lupus Erythematosus," was
presented by Dr. Richard Furie, MD, on Tuesday, November 13, 2012. Dr. Furie
is Chief of the Division of Rheumatology and Allergy-Clinical Immunology at
the North Shore-Long Island Jewish Health System and directs the hospital's
Systemic Lupus Erythematosus (SLE) and Autoimmune Disease Treatment Center.
The poster highlights data from the PEARL-SC clinical study including new
information regarding treatment effects in the broader modified intent to
treat population of lupus patients where 200 mg weekly blisibimod therapy was
associated with statistically significant benefits in predefined SLE Responder
Index (SRI*) endpoints. Specifically, this new data indicates statistically
significant treatment effects using higher thresholds of improvement in
disease score (SELENA/SLEDAI** reductions of 7 and 8) including the recently
FDA reviewed SRI-8 endpoint to be utilized in the phase 3 CHABLIS-SC clinical
studies. These data confirm and expand on previously reported clinical
improvements seen in the population of patients to be enrolled in the
CHABLIS-SC phase 3 clinical studies. These studies will enroll patients with
active disease (SELENA/SLEDAI > 10) who are also receiving corticosteroid
therapy at baseline.
As well, the poster highlighted the positive effects of blisibimod on markers
of renal disease including proteinuria and antibodies to double stranded DNA.
"PEARL-SC provided a great deal of insight into the treatment effect of
blisibimod in patients who continue to have overt clinical manifestations of
their disease, such as a rash and joint pain, despite the addition of
corticosteroid therapy," said Dr. Furie.
"These results validate our earlier findings in patients with severe disease
and provide further confirmation for our choice of study population and
endpoint in the CHABLIS-SC Phase 3 development program," said Colin Hislop,
MD, Anthera's Senior Vice President and Chief Medical Officer. "These data
also provide a sound rationale for our Phase 2 program to examine the utility
of blisibimod as a potential treatment for patients' renal disease, such as
IgA nephropathy and lupus nephritis and encourage further expansion of
inclusion criteria for the CHABLIS-SC2 phase 3 program to include stable
presentations of lupus nephritis."
Abstracts can be accessed on the ACR website at
http://www.acrannualmeeting.org/. The poster will be available on
*SRI is defined as patients who respond to treatment and achieve a reduction
in SELENA-SLEDAI equal to or greater than the number indicated, no new BILAG A
or two B organ domain scores, and no increase in Physician's Global Assessment
(PGA) of greater than 0.3 on a three point scale.
**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 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
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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 September 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., email@example.com or
SOURCE Anthera Pharmaceuticals, Inc.
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