Company Website:
http://www.synergypharma.com
NEW YORK -- (Business Wire)
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced positive
top-line results from the first of two pivotal phase 3 clinical trials
evaluating the efficacy and safety of plecanatide, an investigational
once-daily orally-administered compound, in 1,135 adult patients with
irritable bowel syndrome with constipation (IBS-C).
Preliminary analysis of the data indicates that both plecanatide 3 mg
and 6 mg doses met the study’s primary endpoint and showed statistical
significance in the percentage of patients who were Overall Responders
compared to placebo during the 12-week treatment period (21.5% in 3 mg
and 24.0% in 6 mg dose groups compared to 14.2% in placebo; p=0.009 for
3 mg and p<0.001 for 6 mg). An Overall Responder, as defined by the FDA,
is a patient who fulfills both ≥ 30% reduction in worst abdominal pain
andan increase of ≥ 1 complete spontaneous bowel movement (CSBM)
from baseline, in the same week, for at least 50% of the 12 treatment
weeks.
The most common adverse event was diarrhea which occurred in 3.2% of
patients in 3 mg and 3.7% of patients in 6 mg dose groups compared to
1.3% of placebo-treated patients.
“We are very pleased with these results,” said Gary S. Jacob, Ph.D.,
Chairman and CEO of Synergy Pharmaceuticals Inc. “These data reinforce
our strong belief that plecanatide may represent an important new
treatment option for the millions of patients currently suffering from
IBS-C. We look forward to the results of our second phase 3 IBS-C trial
with plecanatide later this month.”
Four patients in the trial (0.4%) experienced serious adverse events but
there was no imbalance across treatment groups in either incidences or
individual serious adverse events. Overall, the rates of withdrawal from
treatment because of an adverse event were low (1.9% in 3 mg and 1.8% in
6 mg dose groups compared to 0 in placebo) and discontinuations due to
diarrhea were infrequent (0.8% in 3 mg and 1.6% in 6 mg dose groups
compared to 0 in placebo).
Additionally, plecanatide is under review by the Food and Drug
Administration (FDA) for the treatment of chronic idiopathic
constipation (CIC) and the Prescription Drug User Fee Act (PDUFA) target
action date is January 29, 2017. Pending approval in the CIC indication,
the company plans to file a New Drug Application Supplement with
Clinical Data (sNDA) for plecanatide in IBS-C in Q1 2017.
The Plecanatide Phase 3 IBS-C Program
Design
The plecanatide phase 3 IBS-C program includes two randomized, 12-week,
double-blind, placebo-controlled trials evaluating the efficacy and
safety of plecanatide treatment (3 mg and 6 mg doses), taken as a tablet
once-a-day in patients with IBS-C. Both trials included a two-week
pre-treatment baseline period, a 12-week treatment period, and a
two-week post-treatment follow-up period. The phase 3 IBS-C program was
designed to support regulatory submission in the U.S.
The first phase 3 IBS-C trial was conducted in North America and
assessed 1,135 patients (28.2% males and 71.8% females) that were
randomly assigned to take 3 mg or 6 mg plecanatide or placebo once-a-day
during the 12-week treatment period (377 patients in the 3 mg dose
group, 379 patients in the 6 mg dose group and 379 patients in the
placebo group).
Primary Endpoint
The primary endpoint for both trials is the percentage of patients who
are Overall Responders (%) during the 12-week treatment period. An
Overall Responder, as defined by the FDA, is a patient who fulfills both
≥ 30% reduction in worst abdominal pain andan increase of ≥ 1
complete spontaneous bowel movement (CSBM) from baseline, in the same
week, for at least 50% of the 12 treatment weeks. The Overall Responder
endpoint is the current regulatory endpoint required for U.S. approval
in IBS-C.
Patient Population
Patients were selected using Rome 3 criteria for IBS-C. Patients with
IBS-C are defined by Rome III Criteria as having a history of
constipation and abdominal pain for at least 6 months, including hard or
lumpy stools for 25% or more of defecations, loose or watery stools for
25% or less of defecations, and abdominal pain or discomfort for 3 days
or more per month for the last 3 months.
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a chronic, complex condition subtyped
by the predominant stool form: constipation (IBS-C), diarrhea (IBS-D),
or mixed (IBS-M). It is estimated that the prevalence of IBS-C in the
U.S. adult population is approximately 4 to 5 percent, though this
number may vary as patients often fluctuate between the three subtypes
of IBS. IBS is characterized by abdominal pain or discomfort associated
with two or more of the following: improvement with defecation, onset
associated with a change in frequency of stool, or onset associated with
a change in form (appearance) of stool.
About Plecanatide
Plecanatide is a peptide made up of 16 amino acids and, with the
exception of a single amino acid substitution, it is identical to
uroguanylin. Plecanatide is the first investigational drug designed to
replicate the function of uroguanylin, a naturally occurring and
endogenous human GI peptide which acts in a pH-sensitive manner
targeting GC-C receptors primarily in the proximal small intestine.
Plecanatide stimulates fluid secretion and promotes stool consistency
necessary to support normal bowel function.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the development and
commercialization of novel GI therapies. The company has pioneered
discovery, research and development efforts around uroguanylin analogs
for the treatment of functional GI disorders and inflammatory bowel
disease. Synergy’s proprietary uroguanylin analog technology platform
includes two lead product candidates – plecanatide and dolcanatide. For
more information, please visit www.synergypharma.com.
Forward-Looking Statement
Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward- looking words such
as "anticipate," "planned," "believe," "forecast," "estimated,"
"expected," and "intend," among others. These forward-looking statements
are based on Synergy's current expectations and actual results could
differ materially. There are a number of factors that could cause actual
events to differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, substantial
competition; our ability to continue as a going concern; our need for
additional financing; uncertainties of patent protection and litigation;
uncertainties of government or third party payer reimbursement; limited
sales and marketing efforts and dependence upon third parties; and risks
related to failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations. As with any pharmaceutical under
development, there are significant risks in the development, regulatory
approval and commercialization of new products. There are no guarantees
that future clinical trials discussed in this press release will be
completed or successful or that any product will receive regulatory
approval for any indication or prove to be commercially successful.
Investors should read the risk factors set forth in Synergy's Form 10-K
for the year ended December 31, 2015 and other periodic reports filed
with the Securities and Exchange Commission. While the list of factors
presented here is considered representative, no such list should be
considered to be a complete statement of all potential risks and
uncertainties. Unlisted factors may present significant additional
obstacles to the realization of forward-looking statements.
Forward-looking statements included herein are made as of the date
hereof, and Synergy does not undertake any obligation to update publicly
such statements to reflect subsequent events or circumstances.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161209005270/en/
Contacts:
Synergy Pharmaceuticals Inc.
Gem Hopkins, 212-584-7610
VP,
Investor Relations and Corporate Communications
ghopkins@synergypharma.com
Source: Synergy Pharmaceuticals Inc.
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