Anthera Announces First Patient Screened in RESULT Pivotal Phase 3 Clinical Study of Sollpura
May 15 2017 - 4:02PM
Anthera Pharmaceuticals. (Nasdaq:ANTH) today announced that it has
commenced screening in the RESULT Phase 3 clinical study of
Sollpura for exocrine pancreatic insufficiency due to cystic
fibrosis. Based on feedback from the US FDA, this
non-inferiority study will compare the efficacy of Sollpura, a
biologically manufactured pancreatic enzyme replacement therapy
(PERT), to Pancreaze, a porcine-extracted PERT, as assessed by CFA
after 4 weeks of treatment. Topline data are expected at the end of
2017 or early 2018, depending on the speed of patient enrollment.
“As a key investigator in the SOLUTION study and now
participating in the RESULT study, I am excited to be part of this
important study for Cystic Fibrosis patients with exocrine
pancreatic insufficiency. Sollpura has the potential to
address an unmet need for PERTs with a reduction in pill burden, as
well as the benefit of a product that is not extracted from pigs,”
shared Dr. Steven R. Boas, M.D., FAAP,
FACSM President and CEO, The Cystic Fibrosis
Institute, Glenview, IL.
The RESULT clinical study builds upon data from the previous
Sollpura trial (SOLUTION) and allows for more frequent and higher
dose adjustments based upon clinical signs and symptoms. As
with current practice with porcine enzymes, the RESULT study allows
patients to increase their daily dose to an individualized dose
that achieves maximum therapeutic benefit, while maintaining a
potential reduction in daily pill burden as compared to porcine
PERTs.
“We are very pleased to achieve this important milestone for
Sollpura,” shared William Shanahan, Chief Medical Officer, “and we
appreciate the input from the US FDA and members of the CF
Community in the design of RESULT. There is enthusiasm within
patient and provider communities for a non-porcine derived product
and we look forward to this important study.”
About RESULT
The Phase 3 RESULT study is designed to evaluate the
non-inferiority of Sollpura at individualized doses compared to
approved, porcine-derived, enteric-coated PERT when administered to
patients with exocrine pancreatic insufficiency due to cystic
fibrosis. The study will enroll patients (N≈150) with
exocrine pancreatic insufficiency due to cystic fibrosis who are
well controlled on stable porcine PERT at screening, as
demonstrated by a minimum CFA. The primary efficacy variable
will evaluate the change from baseline in CFA following 4 weeks of
treatment with either Sollpura or Pancreaze. Patients randomized to
Sollpura will then be followed for an additional 20-Week extension
period (total of 24 weeks on study) for additional assessments of
weight, height, BMI, and safety.
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 porcine viral contamination), formulation of enzymes
in a precise and fixed ratio, stability in acid pH without enteric
coating, and 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 require gastric tubes in order to
maintain appropriate nutritional health.
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 and IgA nephropathy. Additional information on
Anthera 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-K for the year ended
December 31, 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:
Investor Relations of Anthera Pharmaceuticals, Inc.
ir@anthera.com
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