Anthera Pharmaceuticals Announces Continuation of SIMPLICITY Study of Sollpura™ Following Positive DMC Review
December 13 2016 - 8:30AM
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced that
the Data Monitoring Committee (DMC) completed its pre-planned
safety review of the SIMPLICITY clinical study of Sollpura supplied
as a powder for oral solution in an initial cohort of cystic
fibrosis patients seven years of age and older with exocrine
pancreatic insufficiency. The DMC was in unanimous agreement “that
there are no safety concerns and that the study can move forward to
enrolling Part B,” which will enroll patients from 28 days to 6
years of age.
The SIMPLICITY study evaluates the safety and efficacy of
Sollpura powder for oral solution which supplies the digestive
enzymes in sachets that are dissolved into water or apple juice and
drunk with meals. This study is being conducted in 2 parts in
patients with exocrine pancreatic insufficiency due to cystic
fibrosis. An initial evaluation of safety in patients aged 7
years and older has been completed before commencing enrollment of
younger patients aged 28 days to 6 years into Part B.
Anthera can now begin screening and enrollment activities for
Part B of the SIMPLICITY study following the positive outcome of
the DMC review. In Part B, Sollpura powder for oral solution will
be administered to pediatric patients ranging in age from 28 days
to 6 years. Efficacy will be measured based on the observed
coefficient of fat absorption following seven weeks of open-label
treatment with Sollpura.
Anthera plans to report topline data including efficacy and
safety data in the second quarter of 2017. Topline data from the
Phase 3 SOLUTION clinical study evaluating the efficacy and safety
of the capsule formulation of Sollpura remains on track for this
quarter.
About Sollpura (liprotamase)
Sollpura is a novel, non-porcine PERT containing a proprietary,
biotechnology-derived formulation of cross-linked crystalline
lipase, crystalline protease, and amorphous amylase with broad
substrate specificity, that has been designed for purity (no
potential for viral contamination), precise dose standardization,
resistance against proteolysis without polymeric coating, and
stability in acid pH for reliable potency of activity in the
proximal small intestine.
Sollpura represents potentially the first soluble, stable and
non-pig derived enzyme product to offer a solution to people with
EPI, including young children and adults, who are either unable to
swallow multiple pills or are forced to use gastric tubes in order
to maintain appropriate nutritional health. Unlike other enzyme
products for the treatment of EPI derived from pig pancreas, the
purified enzymes in Sollpura exhibit enhanced solubility and
stability that make it an ideal product to be conveniently
co-administered with a variety of liquids and food products.
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: Nikhil Agarwal of Anthera Pharmaceuticals, Inc.
nagarwal@anthera.com or 510.856.5600 x5621
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