HAYWARD, Calif., Feb. 10, 2015 /PRNewswire/ -- Anthera
Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced the successful
completion of an interim analysis of its Phase 3 trial
(CHABLIS-SC1) of blisibimod in patients with Systemic Lupus
Erythematosus and that the study should continue to completion as
planned. An independent statistician conducted the interim futility
analysis for the CHABLIS-SC1 study, evaluating the SRI-6 response
at the 24 week time point. Enrollment in the trial is projected to
conclude in mid-2015.
"While the results of the CHABLIS-SC1 interim futility analysis
remain blinded to Anthera, we are very pleased that the study has
passed this critical milestone and now look forward to finishing
enrollment later this year," said Dr. Colin
S. Hislop, Anthera's Chief Medical Officer.
Prior to the interim analysis and in response to recent input
from the Company's Scientific Advisory Board following the
publication of clinical data from other Lupus studies with BAFF
inhibitors, the Company modified the primary endpoint of
CHABLIS-SC1 from SRI-8 response to SRI-6 response, which was
previously a secondary endpoint of the study. SRI-8 will
remain a key secondary endpoint of the study. The Systemic Lupus
Erythematosus Response Index (SRI) is an approved endpoint
recognized by the FDA for previously approved therapeutics.
"Based on the wealth of new information regarding the treatment
of SLE and BAFF inhibition, we are fortunate to have had the
opportunity to adjust our trial design," said Dr. Colin S. Hislop. "The SRI-6 endpoint has a
history of consistency across multiple trials and represents the
best possibility for success. Maintaining the SRI-8 endpoint as a
key secondary endpoint can maximize our commercial opportunity for
the severe patients we are enrolling in the CHABLIS-SC1 study."
Anthera has also completed a Scientific Advice Process meeting
with the European Medicines Agency (EMA) regarding the blisibimod
development program for the treatment of IgA Nephropathy (IgAN).
Earlier this quarter the Company obtained written feedback
regarding the acceptability of a single pivotal study as the
initial basis for a conditional market authorization application
(MAA) in the European Union utilizing proteinuria as the primary
endpoint. In addition, the EMA also provided recommendations
to address treatment duration, durability of response and need for
re-treatment in the BRIGHT-SC study. Anthera and its Japanese
development partner Zenyaku Koygo Co., Ltd. plan to incorporate
them in a protocol amendment prior to the planned interim analysis
for the BRIGHT-SC study which will be completed later this
quarter.
"We are pleased by the feedback from the EMA on the IgAN
development program, which supports our global approach in IgAN.
This comes at a time when we are actively expanding our
recruitment efforts throughout the world," said Dr. Colin S. Hislop.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused
on developing and commercializing products to treat serious and
life-threatening diseases, including systemic lupus erythematosus,
IgA nephropathy, and exocrine pancreatic insufficiency due to
cystic fibrosis.
About Blisibimod
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 FC-fusion protein,
or peptibody, and is distinct from an antibody. BAFF is a tumor
necrosis family member and is critical to the development,
maintenance and survival of B-cells. Abnormal elevations of B-cells
and BAFF may lead to an overactive immune response, which can
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 IgAN.
About Sollpura (liprotamase)
Sollpura is a soluble, stable and non-porcine enzyme product
intended for the treatment of patients with Exocrine Pancreatic
Insufficiency (EPI) due to cystic fibrosis, and potentially other
diseases. EPI is characterized by low absorption of fat and other
nutrients due to a reduction in digestive enzymes produced by the
pancreas. Unlike other enzyme products for EPI, Sollpura's
chemical characteristics make it ideal for formulation as either a
capsule or sachet product for co-administration with a variety of
food products.
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, 2013 and Quarterly
Report on Form 10-Q for the quarter ended September 30, 2014. 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., dlutz@anthera.com or 510.856.5598.
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SOURCE Anthera Pharmaceuticals, Inc.