Anthera Pharmaceuticals Surpasses 50% Milestone for Screening of Patients in RESULT Phase 3 Clinical Study of Sollpura in Cys...
September 07 2017 - 8:30AM
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced that
the screening for the RESULT Phase 3 clinical study has surpassed
the halfway mark. RESULT is studying the use of a more
frequent and flexible dosing of Sollpura for the treatment of
exocrine pancreatic insufficiency (EPI) due to cystic
fibrosis. Topline data are expected at the end of 2017 to
early 2018.
"The rapid pace of screening in the RESULT study is a testament
to the need for a new therapeutic option for cystic fibrosis
patients and caregivers. As we move forward with screening and
enrollment, we remain excited about this alternative treatment for
EPI patients who are unable to maintain appropriate nutritional
health, and especially for those who seek soluble or non-porcine
therapeutic options." Said Michael W. Konstan, M.D., Vice Dean for
Translational Research, Gertrude Lee Chandler Tucker Professor of
Pediatrics, Case Western Reserve University School of Medicine
“We are very pleased that more than 50% of the anticipated
patients needed to complete enrollment have entered screening for
the RESULT trial. The acceleration of recruitment in recent weeks
has been encouraging and validating for the need for an
alternative to today’s current enzyme therapies,” said William
Shanahan, MD, Chief Medical Officer of Anthera.
The RESULT study 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 from Sollpura. Sollpura is potentially the first
non-porcine Pancreatic Enzyme Replacement Therapy (“PERT”), which
could provide a potential reduction in the size and number of daily
pills patients must administer due to a significantly more compact
formulation than porcine PERTs.
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
transmission and increased risk of gout, renal impairment and
hyperuricemia. 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.
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Contact Information
CONTACT: Investor Relations of Anthera Pharmaceuticals, Inc.
ir@anthera.com
For Media Inquiries:
Frannie Marmorstein
rbb Communications
frannie.marmorstein@rbbcommunications.com
305-567-0821
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