Evoke Pharma Reports Topline Results from EVK-001 Phase 3 Clinical Trial
July 18 2016 - 8:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced topline results from its Phase 3 clinical trial of
EVK-001 in female patients with symptomatic diabetic gastroparesis.
In this study, EVK-001, the Company's patented nasal delivery
formulation of metoclopramide for the relief of symptoms associated
with acute and recurrent diabetic gastroparesis in adult women, did
not achieve its primary endpoint of symptom improvement at Week 4.
Preliminary review of topline data across all study
sites revealed similar improvement in the EVK-001 and placebo
groups at Week 4 as measured by the total symptom score as well as
the individual scores for each of the signs and symptoms, but these
results were not consistent across the study sites. Further
evaluation of topline data revealed diary data from 28 of 41 of the
enrolling sites showed a statistically-significant benefit at Week
4 for EVK‑001 (p=0.006) in contrast to results from the other 13
sites that showed statistically significant benefit for placebo
(p=0.002). Once the complete datasets and PK data are available,
additional analyses will be conducted to further understand the
discrepant results.
Safety results were consistent with findings from
previous EVK-001 studies that showed the nasal formulation of
metoclopramide has a favorable safety profile and is well-tolerated
by healthy volunteers and patients with diabetic gastroparesis. In
this Phase 3 study, there were slightly more reports of nasal
irritation in subjects receiving placebo than in subjects receiving
EVK-001.
The study was a U.S.-based, multicenter,
randomized, double-blind, placebo-controlled Phase 3 clinical trial
to evaluate the efficacy, safety and population pharmacokinetics
(PK) of EVK-001 in 205 adult female subjects with diabetic
gastroparesis who received EVK-001 or placebo four times daily for
four weeks. The primary endpoint was the change in symptoms from
the baseline period to Week 4 as measured using a proprietary
Patient Reported Outcome (PRO) instrument. The PRO was used to
calculate a weekly score based on daily telephone diary entries by
study subjects who reported the frequency and severity of their
gastroparesis signs and symptoms.
"The topline results are unexpected and an anomaly,
given that metoclopramide has been approved and used for treating
diabetic gastroparesis for more than 35 years. Additionally,
EVK-001 provides predictable absorption of metoclopramide as seen
in our prior trials,” stated Dave Gonyer, R.Ph., President and CEO.
“We continue to believe that EVK-001 is a promising treatment
option for patients who currently rely on oral drugs to treat their
symptoms of gastroparesis. Our analysis will continue as the
remainder of the data become available and an update will be
provided when we have more clarity on our steps ahead.”
About Evoke Pharma, Inc.Evoke is a
specialty pharmaceutical company focused primarily on the
development of drugs to treat GI disorders and diseases. The
Company is developing EVK-001, a metoclopramide nasal spray for the
relief of symptoms associated with acute and recurrent
gastroparesis in women with diabetes mellitus. Diabetic
gastroparesis is a GI disorder afflicting millions of sufferers
worldwide, in which the stomach takes too long to empty its
contents resulting in serious digestive system symptoms.
Metoclopramide is the only product currently approved in the United
States to treat gastroparesis, and is currently available only in
oral and intravenous forms. EVK-001 is a novel formulation of this
drug, designed to provide systemic delivery of metoclopramide
through nasal administration. Visit www.EvokePharma.com for more
information.
Safe Harbor Statement Evoke
cautions you that statements included in this press release that
are not a description of historical facts are forward-looking
statements. In some cases, you can identify forward-looking
statements by terms such as "may," "will," "should," "or expect,"
"plan," "anticipate," "could," "intend," "target," "project,"
"contemplates," "believes," "estimates," "predicts," "potential" or
"continue" or the negatives of these terms or other similar
expressions. These statements are based on the company's current
beliefs and expectations. These forward-looking statements include
statements regarding EVK-001 serving as an effective and promising
treatment option for gastroparesis, the absorption of
metoclopramide with EVK-001, and Evoke’s plans to conduct
additional analysis of the trial data and potential next steps for
the Company. The inclusion of forward-looking statements should not
be regarded as a representation by Evoke that any of its plans will
be achieved. Actual results may differ from those set forth in this
press release due to the risk and uncertainties inherent in Evoke's
business, including, without limitation: additional analyses of
data from the Phase 3 trial may produce negative or inconclusive
results, or may be inconsistent with previously announced topline
results; the inherent risks of clinical development of EVK-001;
Evoke is entirely dependent on the success of EVK-001, and Evoke
cannot be certain that it will be able to conduct additional trials
of EVK-001 or obtain regulatory approval for EVK-001; Evoke will
require substantial additional funding to continue to develop
EVK-001, and may be unable to raise capital when needed, including
to fund ongoing operations; Evoke’s ability to comply with the
financial and other covenants under its loan and security agreement
with Pacific Western Bank, which could result in an event of
default and an acceleration of outstanding amounts owed under the
loan; and other risks detailed in Evoke's prior press releases and
in the periodic reports it files with the Securities and Exchange
Commission. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
and Evoke undertakes no obligation to revise or update this press
release to reflect events or circumstances after the date hereof.
All forward-looking statements are qualified in their entirety by
this cautionary statement. This caution is made under the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995.
Investor Contact:
The Ruth Group
David Burke
O: 646-536-7009
C: 917-618-2651
dburke@theruthgroup.com
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