Anthera Pharmaceuticals Announces RESULT Phase 3 Clinical Study of Sollpura will be included in the Cystic Fibrosis Foundatio...
July 10 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
Cystic Fibrosis Foundation Therapeutics Development Network (CFF
TDN) Protocol Review Committee. The CFF TDN approval may result in
additional TDN investigational sites participating in the study
which could further accelerate patient recruitment in the U.S.
Topline data are expected at the end of 2017 or early 2018,
depending on the speed of patient enrollment.
"We are very pleased to leverage the CFF TDN clinical trial
network and are excited by the progress made with the
implementation of the RESULT study," shared William Shanahan, Chief
Medical Officer of Anthera Pharmaceuticals.
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 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,
liprotamase 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 liprotamase 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 March 31, 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
Please contact Investor Relations at ir@anthera.com
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