Anthera Pharmaceuticals Announces RESULT Phase 3 Clinical Study of Sollpura will be Included in the European Cystic Fibrosis ...
August 14 2017 - 8:30AM
Anthera Pharmaceuticals (Nasdaq:ANTH) today announced that the
RESULT Phase 3 clinical study of Sollpura for exocrine pancreatic
insufficiency due to cystic fibrosis has been approved by the
European Cystic Fibrosis Society Clinical Trial Network (ECFS CTN)
Executive Committee. The aim of the ECFS CTN is to intensify
clinical research in the area of cystic fibrosis and to bring new
medicines to patients as quickly as possible. Enrollment in
RESULT, in both the US and EU, is on schedule and inclusion of the
study in the ECFS CTN may further expedite patient recruitment for
the RESULT clinical study. Topline data are expected at the
end of 2017 to early 2018, depending on the speed of patient
enrollment.
"We are very pleased to receive approval by the ECFS Executive
Committee for inclusion of the RESULT trial in the ECFS CTN,” said
Craig Thompson, President & CEO of Anthera. “This achievement,
in combination with the earlier approval from the Cystic Fibrosis
Foundation Therapeutics Development Network, represents another key
milestone for the RESULT trial.”
The RESULT clinical study design evolved from the data in 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 dose increases on an individualized basis to
achieve maximum therapeutic benefit, while maintaining a potential
reduction in daily pill burden due to Sollpura’s significantly more
compact formulation technology.
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 pancreatic enzyme
replacement therapy (PERT) when administered to patients with EPI
due to CF. The study will enroll patients (N≈150) who are
well-controlled on stable porcine PERT at screening, as
demonstrated by the coefficient of fat absorption (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 longer term 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, formulated in a precise and fixed ratio to
provide stability in acidic pH environments, like that found in the
stomach, without enteric coating. Being non-porcine, Sollpura
mitigates porcine-associated risks including supply limitations and
the potential for contamination with pig-associated viral or other
infectious agents. In addition, given its stability in the
absence of enteric coating, a soluble, drinkable formulation of
Sollpura is in development, which may provide an easy-to-administer
option especially for pediatric patients and patients who receive
their nutrition through feeding tubes.
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 Quarterly Report on Form 10-Q for the quarter
ended June 30, 2017. 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
CONTACT: Investor Relations of Anthera Pharmaceuticals,
Inc.ir@anthera.com
For Media Inquiries:Frannie Marmorsteinrbb Communications
frannie.marmorstein@rbbcommunications.com305-567-0821
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