Anthera Announces Initiation of the SOLUTION Clinical Study of Oral Sollpura(R) (liprotamase) Unit-Matched Therapy of Non-Por...
October 02 2015 - 12:34PM
- Study to enroll approximately 130 patients with exocrine
pancreatic insufficiency
- More than 50 clinical sites around the United States and Europe
are expected to participate
- Anthera to host reception at the North American Cystic Fibrosis
Conference to discuss the SOLUTION program.
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced the
initiation of the SOLUTION (Study of
Oral Liprotamase
Unit-Matched Therapy
Of Non-Porcine Origin in People
With Cystic Fibrosis) Phase 3 clinical study evaluating the
efficacy and safety of Sollpura® (liprotamase), a microbial
derived, biotech pancreatic enzyme replacement therapy (PERT),
compared to an approved, porcine-derived, enteric-coated product
for the treatment of exocrine pancreatic insufficiency (EPI).
The Phase 3 SOLUTION clinical study is a multicenter,
randomized, open-label, assessor-blind, non-inferiority,
active-comparator study designed to evaluate the efficacy and
safety of Sollpura in people with EPI due to cystic fibrosis. This
pivotal study is intended to evaluate the non-inferiority of
Sollpura compared with a commercially available PERT in a
population enriched for PERT responders. The primary efficacy
endpoint of this study will be comparative efficacy measured as the
change in the coefficient of fat absorption (CFA) at the end of
therapy. For more information on the SOLUTION clinical study,
please visit https://clinicaltrials.gov/ct2/show/NCT02279498.
"The initiation of the SOLUTION clinical study marks a critical
milestone for Anthera. With its solubility, stability, and absence
of bulky enteric coating, we believe Sollpura has the potential to
significantly improve the lives of people with EPI," said Dr. Colin
Hislop, Anthera's Chief Medical Officer. "We are extremely excited
to advance the Sollpura development program, and today we have
taken another step towards making a much needed treatment available
for people who are unable to maintain appropriate nutritional
health with existing enzyme therapies."
"We extend our sincere appreciation to the Cystic Fibrosis
Foundation for their continued support of this program. They have
been an invaluable resource throughout the development of the
SOLUTION study," said Paul F. Truex, Anthera's President and Chief
Executive Officer. "We look forward to their continued support as
we further the development of Sollpura."
Results from the SOLUTION clinical study are anticipated to
support marketing approval for Sollpura as a treatment for exocrine
pancreatic insufficiency.
On Friday October 9th, 2015 from 8:00 to 10:00 PM, during the
North American Cystic Fibrosis Conference, Anthera will host a
reception to discuss the SOLUTION clinical study with Sollpura. The
reception will be held at the Sheraton hotel, 340 N 3rd Street,
Phoenix, Arizona. To receive an invitation to the event, please
contact Nikhil Agarwal at nagarwal@anthera.com, prior to Wednesday,
October 7th, 2015.
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 Annual Report on Form 10-Q for the quarter
ended June 30, 2015. 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 510.856.5600x5621
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