Anthera Pharmaceuticals Announces Additional Data from Phase 2b PEARL-SC
Two oral presentations at EULAR will review the impact of blisibimod on renal
biomarkers and improved outcomes in systemic lupus erythematosus (SLE)
HAYWARD, Calif., May 7, 2013
HAYWARD, Calif., May 7, 2013 /PRNewswire/ --Anthera Pharmaceuticals, Inc.
(Nasdaq: ANTH), a biopharmaceutical company focused on developing and
commercializing products to treat autoimmune diseases, today announced that
additional data from its Phase 2b PEARL-SC study will be presented in two
lecture sessions at the European League Against Rheumatism (EULAR) Annual
European Congress of Rheumatology in Madrid, Spain.
Dr. Richard Furie, M.D., Chief of the Division of Rheumatology and
Allergy-Clinical Immunology at the North Shore-Long Island Jewish Health
System, will give two presentations summarizing the findings from the recently
completed PEARL-SC Phase 2 trial with blisibimod in patients with SLE:
Novel Treatment in SLE and Sjögren's Syndrome (10:15-11:45 AM, June 13^th),
"Effects of Blisibimod, a Subcutaneous Inhibitor of B-Cell Activating Factor,
in Patients with SLE"
New Drugs for Lupus: State of the Art (1:30-3:00 PM June 13^th),
"Effects of Blisibimod, an Inhibitor of B-Cell Activating Factor, on Markers
of Renal Disease in Patients with SLE."
The presentations will summarize findings from a prospective analysis of the
PEARL-SC clinical study demonstrating the treatment benefit of blisibimod on
markers of renal disease including proteinuria Complement C3 and
double-stranded DNA antibodies (ds-DNA). The presentation will also summarize
the clinical effect of blisibimod on a predefined subgroup of lupus patients
with more severe disease characterized by a SELENA-SLEDAI greater than or
equal to 10 despite receiving corticosteroid therapy at baseline.
Anthera will be hosting a breakout session following the presentations by Dr.
Furie. Please contact firstname.lastname@example.org for the event details.
Two recent presentations by Dr. Morton Scheinberg, M.D., at the 10^th
International Congress on Systemic Lupus Erythematosus in Buenos Aires,
Argentina, highlighted the effects of blisibimod on patients with more severe
SLE. "Blisibimod looks promising when evaluated using the SRI-8 endpoint in
patients with more severe lupus," said Dr. Scheinberg. "The corroboration of
the main study findings in the subgroup of patients from Latin America lends
greater confidence to the observed outcomes. The significant improvements in
proteinuria observed with blisibimod are clearly important to patients with
lupus, and possibly also to patients with other autoimmune renal diseases with
autoantibody-associated kidney damage." The poster "Clinical Experience in
Latin America with Blisibimod Amongst Subjects with Active, Moderate-to-Severe
Systemic Lupus Erythematosus: Data from the Phase 2b PEARL-SC Study" and
presentation "Blisibimod, an Emerging Subcutaneous Biologic Therapy for
Patients with Active, Moderate-to-Severe Systemic Lupus Erythematosus" are
available on www.anthera.com.
About Blisibimod and PEARL-SC
Anthera is developing blisibimod, a selective inhibitor of B-cell activating
factor (BAFF), to explore its clinical utility in various autoimmune diseases
including systemic lupus erythematosus (SLE) and IgA nephropathy. Blisibimod
is a novel fusion protein, or peptibody, and is distinct from an antibody.
Anthera owns worldwide rights to blisibimod in all potential indications.
BAFF, also known as BLyS (B lymphocyte stimulator), is a tumor necrosis family
member and is critical to the development, maintenance and survival of
B-cells. B-cells represent a critical component of human immune response to
infection and other pathogens.However, abnormal elevations of B-cells and
BAFF may lead to an overactive immune response which may damage normal healthy
tissues and organ systems.Multiple clinical studies with BAFF antagonists
have reported the potential benefit of BAFF inhibitors' in treating patients
with lupus and rheumatoid arthritis.
In April 2012, Anthera completed the PEARL-SC Phase 2b clinical study to
evaluate the efficacy and safety of subcutaneous blisibimod in patients with
active and seropositive lupus. In June and July of 2012 Anthera announced
results from PEARL-SC which led to the initiation of a Phase 3 registration
plan utilizing the 200mg weekly dose of blisibimod in patients who were
afflicted with active lupus despite receiving corticosteroids.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals, Inc. is a biopharmaceutical company focused on
developing and commercializing products to treat autoimmune diseases.
Anthera's Phase 3 development product candidate, blisibimod, targets elevated
levels of B-cell activating factor, or BAFF, which has been associated with a
variety of B-cell mediated autoimmune diseases, including systemic lupus
erythematosus (SLE), or lupus, Immunoglobin A nephropathy, or IgAN, lupus
nephritis, vasculitis, rheumatoid arthritis, idiopathic thrombocytopenia
purpura, and others.
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, 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: Dennis Lutz of Anthera Pharmaceuticals, Inc., email@example.com or
SOURCE Anthera Pharmaceuticals, Inc.
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