Anthera Pharmaceuticals Announces Positive Outcome of Interim Futility Analysis in the Phase 3 RESULT Clinical Study of Sollp...
December 11 2017 - 08:30AM
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced a
positive outcome of the pre-specified interim futility analysis for
the RESULT Phase 3 clinical study of Sollpura for the treatment of
Exocrine Pancreatic Insufficiency (“EPI”). The interim
futility analysis was conducted by RESULT’s Data Monitoring
Committee which is comprised of experts appointed by the Cystic
Fibrosis Foundation’s Therapeutics Development Network.
Anthera completed patient recruitment in the RESULT study in
November 2017, and based on the interim futility analysis, the
study will proceed, as planned, with topline data expected in Q1
2018.
“The positive outcome of the interim futility analysis increases
our confidence in the RESULT trial design, and marks the
achievement of another major milestone in the clinical development
of Sollpura,” shared Craig Thompson, President & Chief
Executive Officer. “We would like to thank the patients,
study investigators, the US and European Cystic Fibrosis
Foundations, and the cystic fibrosis community for the support they
have provided as we bring this potential therapy to patients.”
The RESULT study allows for more frequent and higher dose
adjustments based upon clinical signs and symptoms than the
previous Phase 3 SOLUTION study. As with current practice
with porcine pancreatic enzyme replacement therapies (“PERTs”), the
RESULT study allows for dose titrations of Sollpura on an
individualized basis to achieve maximum therapeutic benefit.
Sollpura has the potential to become the first non-porcine PERT,
which may provide a reduction in the size and number of pills
patients must consume daily due to the significantly more compact
formulation of Sollpura than porcine PERTs.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on developing products to treat serious and
life-threatening diseases, including exocrine pancreatic
insufficiency and B-cell associated renal diseases.
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. Such
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,
including but not limited to those set forth in Anthera's public
filings with the SEC, including Anthera's Quarterly Report on
Form 10-Q for the quarter ended September 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:
Investor Relations of Anthera Pharmaceuticals,
Inc.ir@anthera.com
For Media Inquiries:Frannie Marmorstein,
305-567-0821frannie.marmorstein@rbbcommunications.com
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Source: Anthera Pharmaceuticals, Inc.
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