Evoke Provides Additional Data Demonstrating Statistically Significant Benefit for Gimoti in Moderate to Severe Patients in P...
January 04 2017 - 8:30AM
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases,
today provided additional data from the Phase 3 trial of Gimoti,
its nasal delivery of metoclopramide for the relief of symptoms
associated with acute and recurrent diabetic gastroparesis in adult
women. Although the Phase 3 trial failed to reach its primary
endpoint, data also demonstrated that patients with moderate to
severe symptoms, which included 105 of the 205 patients (51%)
enrolled in the study, responded statistically significantly better
when treated with Gimoti than those treated with placebo at
multiple time points in the Intent-to-Treat (ITT) and Per Protocol
populations (Table 1). There were also clinically and statistically
significant improvements in nausea and abdominal pain, which are
two of the more severe and debilitating symptoms of gastroparesis
(Table 2).
These results in patients with moderate to
severe symptoms are 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(Gastroparesis: Clinical Evaluation of Drugs for Treatment, Draft
Guidance). This guidance represents the FDA’s current thinking on
the evaluation of treatments for gastroparesis and states that
trials should enroll patients with higher symptom severity in order
to optimize the ability to demonstrate a treatment effect. At the
time this guidance was issued, the Company’s Phase 3 study,
designed to include patients with a range of symptom severity, had
been actively enrolling for more than a year. The overall efficacy
results were not significant, due in large part to the milder
patients who responded to placebo. Importantly, the efficacy of
Gimoti was demonstrated in the subset of patients described in the
guidance, i.e., those who entered the study with higher symptom
severity.
Phase 3 safety data revealed no significant
adverse effects and 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 metoclopramide
(Table 3). There have been no reports of tardive dyskinesia among
the 1,311 exposed healthy volunteers and patients over the clinical
development program.
“As our discussions with the FDA progressed over
the past few months, we have continued to analyze data from our
Phase 3 trial of Gimoti. These additional analyses have provided us
with important insights regarding the efficacy of Gimoti in
patients with varying levels of symptom severity, despite not
reaching the trial’s primary endpoint,” stated Dave Gonyer, R.Ph.,
President and CEO. “Among the more significant outcomes from these
analyses was the statistically significant and clinically
meaningful improvement in symptom scores in moderate and severe
patients which consisted of a large portion of the overall study
population. In this group, those treated with Gimoti reported
significantly better results than those who received placebo with
benefits seen as early as study week one. It is also important to
note that nausea and abdominal pain, two of the more severe and
common symptoms of gastroparesis, showed the most improvement in
patients receiving Gimoti. These symptom benefits were also
observed in our Phase 2B trial.”
“Patients suffering from moderate to severe
flares of gastroparesis who do not respond to treatment with oral
metoclopramide often require hospitalization, which creates a
significant market opportunity. Gimoti offers patients an
outpatient option that can be delivered consistently even during
symptom flares characterized by nausea and vomiting. The
consistently favorable safety profile of Gimoti among patients
treated in our clinical trials and the benefits we have
demonstrated, indicate that Gimoti can have a positive impact on
the lives of these patients used prior to, and outside of, a
hospital setting,” concluded Mr. Gonyer.
The 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 and was not statistically
significant in the ITT group (N=205, p=0.881). Safety and
additional efficacy results are summarized in the tables below.
Table 1: Phase 3 Estimated Mean Change from
Baseline in Mean Daily GSA Total Scores: Moderate to Severe Study
Populations |
|
Population |
TimePeriod |
Placebo1 |
Gimoti1 |
p-value2 |
Intent-to-Treat |
Week 1Week 2Week 3Week 4 |
(N = 53)-0.387-0.614-0.749-0.856 |
(N = 52)-0.588-0.950-1.096-1.220 |
0.0360.0250.039
0.085* |
Per Protocol |
Week 1Week 2Week 3Week 4 |
(N = 40)-0.362-0.625-0.714-0.841 |
(N = 38)-0.623-1.040-1.286-1.373 |
0.0190.0150.0030.014 |
Table 2: Mean Change from Baseline in Mean Daily Nausea and
Upper Abdominal Pain Score in Intent‑to‑Treat Population with
Moderate to Severe Symptoms |
|
Symptom |
TimePeriod |
Placebo1(N = 53) |
Gimoti1(N = 52) |
p-value2 |
Nausea |
Week 1 |
-0.370 |
-0.859 |
0.001 |
Week 2 |
-0.696 |
-1.149 |
0.032* |
Week 3 |
-0.818 |
-1.242 |
0.043 |
Week 4 |
-0.905 |
-1.404 |
0.027 |
UpperAbdominal
Pain |
Week 1 |
-0.394 |
-0.641 |
0.025 |
Week 2 |
-0.554 |
-0.990 |
0.016 |
Week 3 |
-0.690 |
-1.194 |
0.008 |
Week 4 |
-0.791 |
-1.218 |
0.047 |
1 LSMean from ANCOVA2 p-value is obtained from an ANCOVA model
with fixed effect for treatment group and the baseline value as a
covariate. If the normality assumption was not met, the p-value was
obtained from a rank ANCOVA test and denoted with an *.
|
Table 3: Selected Treatment-Emergent
Adverse Events Reported by More than 2 Subjects in Any Treatment
Group |
|
Adverse Event |
Placebo (N = 103) |
Gimoti (N = 102) |
Headache |
7 (7%) |
5 (5%) |
Nasal discomfort |
4 (4%) |
1 (1%) |
Epistaxis |
2 (2%) |
1 (1%) |
Fatigue |
1 (1%) |
2 (2%) |
|
|
|
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," , 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
potential for Gimoti to have a positive impact on the lives of the
patients who use it. 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: the
data reported only includes a portion of the patients in the Phase
3 clinical trial of Gimoti and that the Phase 3 trial failed to
reach its primary endpoint; risks associated with successfully
commencing and receiving favorable results from the planned
pharmacokinetic trial; later developments with the FDA that may be
inconsistent with the already completed pre-NDA meetings, including
that the FDA will not accept selected data from our Phase 3
clinical trial; the FDA may change its recommendations regarding
evaluation of drugs for the treatment of gastroparesis; 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 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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