Evoke Pharma Announces Collaboration with Spaulding Clinical Research for the Gimoti Comparative Exposure Pharmacokinetic Tri...
April 18 2017 - 8:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that the Company has reached an agreement to work
in partnership with Spaulding Clinical Research for its planned
comparative exposure pharmacokinetic (PK) trial for its lead
product candidate, Gimoti™, a patented nasal delivery formulation
of metoclopramide for the relief of symptoms associated with acute
and recurrent diabetic gastroparesis in adult women. The pivotal PK
trial conducted in healthy volunteers is designed to establish
bioequivalence with the listed drug, Reglan® Tablets, and may serve
as a basis for the 505(b)(2) new drug application (NDA) planned for
submission to the Food and Drug Administration (FDA).
This PK trial follows recent communications with
FDA regarding the final clinical development steps for the NDA
submission. The Company held a face-to-face pre-NDA meeting
with FDA in December 2016 to propose and discuss this PK trial and
recently confirmed the final protocol design during a Type A
Meeting with FDA last month. The Company engaged Spaulding to
execute this trial and is now in the latter planning stages to
initiate the trial.
“We are very pleased to continue our
relationship with Spaulding Clinical for our PK trial for Gimoti
and remain on schedule to initiate the trial in the second half of
the year. We believe a successful PK trial will conclude our
clinical development work for Gimoti and may provide the final data
needed to complete the 505(b)(2) NDA,” said Marilyn R. Carlson,
DMD, MD, RAC, Chief Medical Officer of Evoke. “Previously, the
Spaulding team successfully initiated and completed our Gimoti
thorough ECG trial in 2014. We look forward to completing the PK
trial in the second half of 2017 with the NDA submission for Gimoti
to follow in late 2017 or early 2018.”
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 Gimoti, 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. Gimoti is a novel formulation of this
drug, designed to provide systemic delivery of metoclopramide
through nasal administration. Visit www.EvokePharma.com for more
information.
Spaulding Clinical Research, LLC is a global
clinical research organization providing a range of Phase 1 – 4
drug development services to the biotechnology and pharmaceutical
industries. Spaulding Clinical Research operates a 200-bed Clinical
Pharmacology Unit, Cardiac Core Laboratory and provides full
Biometrics/Scientific Affairs services. The company was founded in
2007 and is based in West Bend, Wisconsin.
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," "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: Evoke’s
plans to launch the PK trial with Spaulding Clinical; the
possibility that the PK trial may provide the final data necessary
to complete the NDA for Gimoti; the timing of the commencement and
completion of the PK trial and the timing of the NDA submission, if
any, for Gimoti; and the benefits Gimoti may have for patients with
moderate to severe gastroparesis symptoms. 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 risks and uncertainties inherent in Evoke's
business, including, without limitation: risks associated with
successfully commencing and receiving favorable results from the
planned PK trial; later developments with the FDA that may be
inconsistent with the already completed pre-NDA meetings; the
inherent risks of clinical development of Gimoti; Evoke is entirely
dependent on the success of Gimoti, and Evoke cannot be certain
that it will be able to submit an NDA for Gimoti or obtain
regulatory approval for or successfully commercialize Gimoti; risks
associated with manufacturing new formulations of Gimoti for use in
the PK trial; Evoke’s dependence on third parties for the
manufacture of Gimoti as well as Evoke’s dependence on Spaulding
Clinical for the conduct of the PK trial; Evoke may require
additional funding to complete the PK trial and submit the NDA, and
will require substantial additional funding to commercialize
Gimoti, and may be unable to raise capital when needed, including
to fund ongoing operations; Evoke may not be able to successfully
commercialize Gimoti, if approved, as a result of risks associated
with market acceptance, coverage and reimbursement and competing
products; 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
Tram Bui
Tel: 646-536-7035
tbui@theruthgroup.com
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