Anthera Announces that the Blisibimod CHABLIS-SC1 Phase 3 Study Did Not Achieve the Primary Endpoint in Patients with Active ...
November 10 2016 - 7:00AM
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced that
the CHABLIS-SC1 clinical trial with blisibimod for the treatment of
systemic lupus erythematosus (SLE) failed to meet its primary
endpoint based upon the SLE Responder Index-6 (SRI-6) at 52 weeks.
Although 47% of patients in the blisibimod arm versus 42% of
patients in the placebo arm achieved this endpoint, the difference
was not statistically significant. The SRI is a composite
index comprised of SELENA-SLEDAI, BILAG and Physician Global
Assessment criteria. A SRI-6 response requires a decrease of
at least 6 points in SELENA-SLEDAI. The magnitude of
blisibimod treatment effects for other SLE Response (SRI-4, and
SRI-8) also did not achieve statistical significance.
Serum biological markers including B-cells, immunoglobulins, and
complement demonstrated statistically significant treatment effects
consistent with expectations and previous blisibimod clinical
studies in lupus and IgA nephropathy. Adverse events between the
blisibimod and placebo treatment arms were well balanced and
blisibimod was generally well tolerated.
“We are disappointed that the results did not demonstrate a
meaningful improvement in patients’ disease activity as assessed by
SRI endpoints,” said William Shanahan, M.D., Anthera’s Chief
Medical Officer. “We would like to thank the patients, caregivers,
investigators and key opinion leaders who made the CHABLIS-SC1
clinical study possible. It has yielded significant amounts of data
which we look forward to sharing with the scientific community in
the future which we believe will help to further inform the
development of treatments for severe lupus.”
The Company will continue to analyze the data in the coming
weeks from the CHABLIS-SC1 trial in consultation with key lupus
disease thought leaders to expeditiously determine the future of
the blisibimod lupus program including the on-going CHABLIS 7.5
clinical study. As the pharmacological effects on
immunological markers, such as B-cells and immunoglobulins, were as
expected, the company is continuing the development of blisibimod
for the treatment of IgA Nephropathy (IgAN) pending 48 week results
from the ongoing phase 2 BRIGHT study. IgAN has a very
different pathogenesis than systemic lupus, and the pharmacological
activity of blisibimod might prove effective in its treatment.
The Company expects to report 48-week data from the BRIGHT-SC
IgAN study and topline data from the Sollpura™ SOLUTION phase 3
study later this year.
Anthera will host a conference call to further discuss the data
from the CHABLIS-SC1 clinical study.
Conference Call Access:
Date: November 10, 2016
Time: 8:30 am Eastern Time
Conference ID: 18122260
Toll-Free Dial-In Number: (855) 226-3021
International Dial-In Number: (315)
625-6892
About Anthera Pharmaceuticals, Inc.
Anthera Pharmaceuticals is a biopharmaceutical company focused
on developing and commercializing products to treat serious and
life-threatening diseases, including lupus, lupus with
glomerulonephritis, IgA nephropathy, and exocrine pancreatic
insufficiency due to cystic fibrosis. Additional information on the
Company can be found at www.anthera.com.
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 Quarterly Report on Form 10-Q for the quarter
ended September 30, 2016. 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 Information:
Nikhil Agarwal of Anthera Pharmaceuticals, Inc.,
nagarwal@anthera.com or 510.856.5600 x5621
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