Anthera Announces the Phase 3 SOLUTION Study with Sollpura™ in Cystic Fibrosis Patients with Exocrine Pancreatic Insufficie...
December 27 2016 - 4:05PM
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced the top
line results of the SOLUTION clinical study in cystic fibrosis
patients with exocrine pancreatic insufficiency (EPI). The
study narrowly missed the CFA non-inferiority margin of the primary
modified Intent to Treat (mITT) analysis; however, by additional
pre-specified analyses of CFA (mITT-Baseline Observation Carried
Forward and Per Protocol), Sollpura met the non-inferiority
criterion. The study also confirmed that the ratio of the
three enzymes in Sollpura demonstrated an appropriate response in
the coefficient of nitrogen absorption (CNA). CNA is a
measure of protein digestion and absorption and is a key
requirement of Anthera’s planned US FDA regulatory
submission. Anthera expects to release data from the
extension phase of the study in Q1 2017.
In analyzing the results of the SOLUTION study, patients'
ability to increase their doses during the study were hindered
by time restrictions and amounts allowed per protocol, while
other patients were prevented from increasing their dose due to the
daily limit (10,000 lipase units/kg/day) for porcine pancreatic
enzyme replacement therapies (PERTs). Sollpura was generally well
tolerated compared to Pancreaze, although symptoms related to
malabsorption were generally modestly more frequent in the Sollpura
arm.
In addition to the challenges to dose escalation inherent in the
design of the SOLUTION study, analytical techniques for measuring
the activity of lipase enzymes based on duodenal pH of Cystic
Fibrosis patients, indicate that Sollpura may have been under dosed
versus the Pancreaze labeled dose.
Given the robust activity of Sollpura in this study, in the
context of dose titration limitation and apparent reduced dosage
activity, Anthera will initiate activities for an additional
clinical study of Sollpura in patients with EPI due to Cystic
Fibrosis, which Anthera expects will enable optimized dosing and
dose titration. This study will provide investigators and patients
the flexibility to adjust their Sollpura dose based upon
malabsorption symptoms at any time during the study. Anthera
believes that these modifications in the study design will allow
patients to achieve the optimal level of fat absorption as measured
by CFA. The new study will begin in 1Q’17, and Anthera
anticipates only a modest delay in the filing of the BLA around Q1
2018, as the new study will complete concurrently with the
completion of required CMC activities.
“In the SOLUTION study, Sollpura nearly met the non-inferiority
margin with respect to fat absorption, and met the statistical
criterion for nitrogen absorption. The study data suggest that the
deficiency in fat absorption may be addressed by small changes in
study design, including more liberal dose adjustment. A need
for alternative treatments remains for EPI patients who are unable
to maintain appropriate nutritional health, especially those who
seek soluble or non-porcine therapeutic options” said Michael
Konstan, MD, Vice Dean for Translational Research at Case Western
Reserve University School of Medicine.
“Although we are disappointed to narrowly miss the primary
endpoint, we remain encouraged by the overall SOLUTION study
results and look forward to releasing final data from and its 12
week extension phase in the future, the SIMPLICITY study and
continuation of the open-label EASY study. We would
like to thank the patients, investigators and study staff for their
hard work and dedication to our study. We are most grateful for
their commitment to our shared hope of developing new treatments
for exocrine pancreatic insufficiency, and believe that the
shortcomings of Sollpura in SOLUTION can be addressed in the new
study that we plan to initiate in 1Q’17,” said William Shanahan,
M.D., Anthera’s Chief Medical Officer.
Anthera will host a conference call to further discuss the data
from the SOLUTION clinical study.
Conference Call Access:
Date: December 28, 2016
Time: 08:00 AM ET
Conference ID: 45395933
Toll-Free Dial-In Number: (855) 226-3021
International Dial-In Number: (315) 625-6892
About SOLUTION
The Phase 3 SOLUTION study was designed to evaluate the
non-inferiority of Sollpura compared to approved, porcine-derived,
enterically-coated pancreatic enzyme replacement therapy when
administered to patients with exocrine pancreatic insufficiency due
to cystic fibrosis. The study enrolled subjects with exocrine
pancreatic insufficiency due to cystic fibrosis who were well
controlled on stable PERT therapy prior to screening, as
demonstrated by a coefficient of fat absorption (CFA) of at least
80%. The primary efficacy variable evaluated the change from
baseline in CFA following 7 weeks of therapy with either Sollpura
or an alternative porcine PERT to that being taken during
screening. Individualized doses of Sollpura and the PERT
comparator were chosen to match the lipase units of pre-study
PERT. Additional adjustment of the study drug doses was
allowed during the first 2 weeks of study based on clinical signs
of malabsorption up to a maximum allowed dose of 10,000
units/kg/day of lipase. Subjects enrolled into the SOLUTION study
will continue to be followed through Week 20 for additional
assessments of safety and efficacy. For more information on
the SOLUTION clinical study, please visit
http://www.anthera.com/clinical-studies/solution_study/.
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 exocrine pancreatic
insufficiency due to cystic fibrosis and IgA nephropathy.
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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