Sucampo Reports Top-Line Data from Phase 2a Study of Cobiprostone in Patients with PPI-Refractory Non-Erosive Reflux Disease ...
19 April 2016 - 9:00PM
Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global
biopharmaceutical company, today announced top-line data from a
Phase 2a study of cobiprostone in patients with proton pump
inhibitor (PPI)-refractory non-erosive reflux disease (NERD) or
symptomatic gastroesophageal reflux disease (sGERD). While
cobiprostone demonstrated significant benefit in some of the
secondary measures of this exploratory study, the trial did not
meet its primary endpoints and, based on these data, Sucampo
intends to discontinue development of cobiprostone for
PPI-refractory NERD/sGERD.
“At Sucampo, we remain focused on making
scientifically-driven decisions to prioritize those pipeline
candidates with the most potential to address critical unmet needs.
As a result of these new efficacy findings, we have decided to
discontinue development of cobiprostone in NERD/sGERD,” said Peter
Kiener, D. Phil, Chief Scientific Officer of Sucampo. “While these
data did not support the advancement of cobiprostone in this
indication, the data did demonstrate that cobiprostone was
well-tolerated, and this is consistent with our earlier Phase 1
studies. We plan to continue our development of cobiprostone in our
ongoing Phase 2a study for the prevention of oral mucositis – a
disorder with very different underlying pathophysiology and
clinical endpoints. This development plan includes a futility
analysis on the ongoing trial in the second half of this year.”
The randomized, double-blind,
placebo-controlled, multicenter, Phase 2a study in NERD/sGERD
investigated the safety and efficacy of cobiprostone or placebo
administered three times daily over eight weeks in 153 NERD and
sGERD patients. In the study, top-line data indicate that
cobiprostone did not meaningfully improve heartburn symptoms as
determined by patient reported outcomes, the primary endpoint of
the study. Cobiprostone was generally well-tolerated, with the most
common adverse event being mild diarrhea.
Cobiprostone is a locally-acting chloride
channel activator that works to stimulate and protect the mucosal
barrier function and is currently being developed for the
prevention of oral mucositis in patients suffering with head and
neck cancer receiving concurrent radiation and chemotherapy.
About Sucampo Pharmaceuticals,
Inc.
Sucampo Pharmaceuticals, Inc. is focused on the
development and commercialization of medicines that meet major
unmet medical needs of patients worldwide. Sucampo has two marketed
products – AMITIZA, its lead product, and RESCULA – and a pipeline
of product candidates in clinical development. A global company,
Sucampo is headquartered in Rockville, Maryland, and has operations
in Japan, Switzerland and the U.K. For more information, please
visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of
Innovation, are registered trademarks of Sucampo AG. AMITIZA is a
registered trademark of Sucampo AG.
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Sucampo Forward-Looking
Statement
This press release contains "forward-looking
statements" as that term is defined in the Private Securities
Litigation Reform Act of 1995. These statements are based on
management's current expectations and involve risks and
uncertainties, which may cause results to differ materially from
those set forth in the statements. The forward-looking statements
may include statements regarding product development, and other
statements that are not historical facts. The following factors,
among others, could cause actual results to differ from those set
forth in the forward-looking statements: the impact of
pharmaceutical industry regulation and health care legislation;
Sucampo's ability to accurately predict future market conditions;
dependence on the effectiveness of Sucampo's patents and other
protections for innovative products; the effects of competitive
products on Sucampo’s products; and the exposure to litigation
and/or regulatory actions.
No forward-looking statement can be guaranteed
and actual results may differ materially from those projected.
Sucampo undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this
press release should be evaluated together with the many
uncertainties that affect Sucampo's business, particularly those
mentioned in the risk factors and cautionary statements in
Sucampo's most recent Form 10-K as filed with the Securities and
Exchange Commission on March 11, 2016, as well as its filings with
the Securities and Exchange Commission on Forms 8-K and 10-Q since
the filing of the Form 10-K, all of which Sucampo incorporates by
reference.
Contact:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Affairs
1-240-223-3718
staylor@sucampo.com
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