Evoke Successfully Completes Phase 3 Clinical Trial Enrollment of EVK-001 in Women with Symptoms Associated with Diabetic Gas...
April 28 2016 - 11:46AM
Evoke Pharma, Inc. (NASDAQ:EVOK), today announced that it has
successfully completed patient enrollment in its pivotal Phase 3
clinical trial of EVK-001, its patented nasal delivery formulation
of metoclopramide for the relief of symptoms associated with acute
and recurrent diabetic gastroparesis in women.
The four-week, U.S. multicenter, randomized, double-blind,
placebo-controlled Phase 3 clinical trial is evaluating the
efficacy, safety and population pharmacokinetics of EVK-001 in
approximately 200 adult female subjects with diabetic
gastroparesis. The primary endpoint is the change from
baseline in symptom score at week 4 utilizing a proprietary Patient
Report Outcome (PRO) instrument.
“Completing enrollment of our Phase 3 clinical trial of EVK-001
is a monumental step for Evoke, and based on discussions with the
FDA, this pivotal trial is the final study necessary to submit a
New Drug Application (NDA),” said Dave Gonyer, R.Ph., President and
CEO. “We remain confident in the success of our Phase 3 trial based
on the positive results from our large Phase 2b study which
demonstrated safety and statistically significant symptom
improvement in women, who make up 80% of all patients with
gastroparesis.”
Mr. Gonyer continued, “While completing enrollment in the Phase
3 clinical trial, we have been preparing to submit an NDA as soon
as possible, should the results of the study be positive.
Importantly, we completed a Thorough ECG (TQT) study, which
demonstrated that therapeutic and supratherapeutic doses of EVK-001
did not adversely affect the QT interval in healthy subjects, and
we have produced EVK-001 at commercial scale in accordance with the
FDA standards for chemistry, manufacturing and controls. These data
will be submitted as part of our NDA package. This is a very
exciting time for Evoke as our strategic planning and progress
to‑date have placed us in an optimal position to quickly move
toward potential commercialization.”
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: the timing
of data from the Phase 3 clinical trial of EVK-001 and the
potential to replicate the results observed in the prior Phase 2b
study; the sufficiency of such data and the other activities
completed to data providing a basis for the submission of an NDA
for EVK-001 to the FDA and the timing thereof; and the potential
commercialization of EVK-001. 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: the inherent risks of clinical development of EVK-001
and completion of the Phase 3 trial as well as potential delays in
any other clinical trials and studies; Evoke is entirely dependent
on the success of EVK-001, for which it has commenced a Phase 3
clinical trial and male companion trial, and Evoke cannot be
certain that it will be able to obtain regulatory approval for, or
successfully commercialize, EVK-001; the results observed in female
patients with symptoms associated with acute and recurrent diabetic
gastroparesis in Evoke's Phase 2b clinical trial of EVK-001 may not
be predictive of the safety and efficacy results in the Phase 3
clinical trial; Evoke will require substantial additional funding
to potentially commercialize EVK-001 as well as to finance
additional development requirements, and may be unable to raise
capital when needed, including to fund ongoing operations; the
potential for adverse safety findings relating to EVK-001 to delay
or prevent regulatory approval or commercialization; 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
Tel: 646-536-7009
dburke@theruthgroup.com
Media Contact:
The Ruth Group
Kirsten Thomas
Tel: 646-536-7014
kthomas@theruthgroup.com
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