Evoke Pharma Presents Gimoti Efficacy and Safety Data from Phase 3 Trial as Late Breaker at Digestive Disease Week 2017
May 10 2017 - 8:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today announced that data from its Phase 3 trial of Gimoti™, its
patented nasal delivery of metoclopramide for the relief of
symptoms associated with acute and recurrent diabetic gastroparesis
in women, were presented at the Digestive Disease Week® (DDW) 2017
Meeting held in Chicago, Illinois.
The poster presentation entitled “Symptom
Severity Influences Drug Efficacy in Women with Diabetic
Gastroparesis: Results of a Phase 3 Study with Metoclopramide Nasal
Spray” illustrated that patients with moderate to severe symptoms
at study entry, which included 105 of the 205 patients (51%)
enrolled in the study, responded clinically and statistically
significantly better to Gimoti than placebo at multiple time points
in the Intent-to-Treat (ITT) and Per Protocol populations. Focusing
on the benefits in patients with moderate to severe symptoms is
consistent with the U.S. Food and Drug Administration (FDA)
guidance on the clinical evaluation of drugs for the treatment of
gastroparesis issued in July 2015 (Gastroparesis: Clinical
Evaluation of Drugs for Treatment, Draft Guidance).
In the Phase 3 trial, Gimoti was particularly
effective in reducing nausea and upper abdominal pain, the most
common and debilitating symptoms in patients with moderate to
severe symptoms. This was similar to the benefits experienced by
female patients in the Company’s Phase 2b trial. Safety data from
the Phase 3 trial were consistent with favorable results from
previous Gimoti studies. In particular, there were no adverse
events of special interest, such as the central nervous system
(CNS) effects observed with oral and parenteral formulations of
metoclopramide. Based on recent FDA discussions, these data are
anticipated to be submitted as part of a new drug application (NDA)
for Gimoti.
“As we prepare our 505(b)(2) NDA for Gimoti,
including a comparative exposure pharmacokinetic (PK) study,
acceptance of our Phase 3 data as a late breaker for poster
presentation at DDW 2017 provided another opportunity for us to
share the clinical importance of metoclopramide nasal spray for
women suffering from the symptoms of moderate to severe diabetic
gastroparesis,” stated Marilyn R. Carlson, DMD, MD, Chief Medical
Officer. “We are very pleased that DDW accepted this data for
presentation as we believe it is among the most up-to‑the-minute
and novel GI developments that will impact research and the care of
patients.”
The Phase 3 trial was a U.S. multicenter,
randomized, double-blind, placebo-controlled, parallel‑group study
of the efficacy and safety of Gimoti compared to placebo in adult
female subjects with symptomatic diabetic gastroparesis and delayed
gastric emptying. Eligible patients were randomized 1:1 between
Gimoti or placebo administered as a single nasal spray four times
daily; 30 minutes before meals and at bedtime for a total of four
weeks. The primary endpoint was the change in the total symptom
score from baseline to week four. The trial data was not
statistically significant in the ITT group (N=205, p=0.881).
The authors of the presentation were Richard W.
McCallum, MD, Texas Tech University Health Sciences Center, El
Paso, Texas; Ronnie Fass, MD, Case Western Reserve University,
Cleveland, Ohio; Bal R. Bhandari, MD, Delta Research Partners,
Monroe, Louisiana; Marilyn R. Carlson, DMD, MD and Wayne M. Alves,
PhD, Evoke Pharma, Inc., Solana Beach, California.
The data poster is available on the investors
section of the Company’s website, http://investor.evokepharma.com/,
under the “Presentations and Posters” section.
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.
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 present at DDW and discuss the data from its Phase 3 trial
for Gimoti; the benefits Gimoti may have for patients with moderate
to severe gastroparesis symptoms; the timing of any 505(b) (2) NDA
submission for Gimoti with the FDA; the Company’s plans to conduct
the comparative exposure PK study and include the results in the
Gimoti NDA; and the utility of the Gimoti data to scientists and
clinicians at DDW. 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, including inconsistent conclusions reflected in the
official meeting minutes from the FDA; the inherent risks of
clinical development of Gimoti, in particular since the Phase 3
trial failed to reach its primary endpoint in the ITT population;
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 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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