Evoke Pharma Completes Dosing for Gimoti™ Comparative Exposure Pharmacokinetic Study
September 12 2017 - 8:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that it has completed subject dosing for a
comparative exposure pharmacokinetic (PK) study comparing Gimoti to
the listed drug, Reglan® Tablets. Gimoti is the company’s lead drug
candidate for the treatment of symptoms associated with acute and
recurrent diabetic gastroparesis. The company expects to announce
data from the trial in the fourth quarter of 2017, followed by a
505(b)(2) New Drug Application (NDA) submission by the end of 2017
or early 2018.
The study was designed to demonstrate that a
proposed dose of Gimoti has a similar systemic exposure to that of
the listed drug, Reglan Tablets. The study, conducted at a single
study site, is a single dose, 4-way crossover design that enrolled
approximately 100 healthy volunteers who each received Reglan
Tablets and three different doses of Gimoti in a random
sequence.
“We believe the completion of this comparative
exposure PK study will mark the final clinical milestone for our
development program of Gimoti.” commented Dave Gonyer, R.Ph.,
President and CEO. “As we have mentioned in the past and as we have
discussed with the U.S. Food and Drug Administration (FDA) in our
previous meetings, the PK study results will be used as part of an
NDA submission for Gimoti along with considerable data we’ve
generated over the last decade of development. We remain confident
that Gimoti, our nasal formulation of metoclopramide, has the
potential to improve the lives of those suffering from
gastroparesis, and we look forward to providing further updates on
our progress in the coming months.”
As a reminder, Dave Gonyer will be presenting at
the 19th Annual Rodman & Renshaw Global Investment Conference
today, September 12, 2017 at the Lotte New York Palace Hotel in New
York City. The presentation will begin at 10:00 a.m. EDT and will
take place in the Louis Room.
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 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.
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 include the PK data in the 505(b)(2) NDA for Gimoti; the
timing of announcement of the results of the PK trial and the
timing of the submission of the NDA to the FDA; Evoke’s expectation
that the PK trial will be the final clinical trial for Gimoti; and
Evoke’s belief that there is a large unmet need for an effective
treatment for diabetic gastroparesis. 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 conducting,
completing and receiving favorable results from the PK trial; later
developments with the FDA that may be inconsistent with the already
completed pre-NDA meetings, including inconsistent conclusions
reflected in the official meeting minutes from the FDA; 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 the submission of the NDA; Evoke’s
dependence on Spaulding Clinical Research to conduct 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; 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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