EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Other Events
Item8.01
| Other Events |
On January4, 2017, Evoke Pharma, Inc. (the Company) a specialty
pharmaceutical company focused on treatments for gastrointestinal
(GI) diseases, 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Evaluation of Drugs for Treatment, Draft Guidance).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 FDAs 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 Companys 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.
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.
Table1: |
Phase 3 Estimated Mean Change from Baseline in Mean Daily GSA Total Scores: Moderate to Severe Study Populations |
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Table2: |
Mean Change from Baseline in Mean Daily Nausea and Upper Abdominal Pain Score in Intent-to-Treat Population with Moderate to Severe Symptoms |
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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 | |||||
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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 |
| LSMean from ANCOVA |
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p-value is obtained from an ANCOVA model with fixed effect for treatment group and the baselinevalue as a covariate. If the normality assumption was not met, the p-value was obtained from a rankANCOVA test and denoted with an *. |
Table3: |
Selected Treatment-Emergent Adverse Events Reported by More than 2 Subjects in Any Treatment Group |
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7 (7%) | 5 (5%) | ||
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4 (4%) | 1 (1%) | ||
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2 (2%) | 1 (1%) | ||
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1 (1%) | 2 (2%) |
Forward-Looking Statements.
The Company cautions you that statements included in this Current
Report on Form 8-K 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 companys 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 the Company 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 the
Companys 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-new drug application (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; the Company is entirely dependent on the success of
Gimoti, and the Company 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
pharmacokinetic (PK) trial; the Companys dependence on third
parties for the manufacture of Gimoti as well as the conduct of
the PK trial; the Company 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; the Company 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
the periodic reports the Company 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 the Company 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.
About EVOKE PHARMA, INC. (NASDAQ:EVOK)
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women. EVK-001 is a formulation of Metoclopramide drug, designed to provide systemic delivery of metoclopramide through intranasal administration. The Company has evaluated EVK-001 in a multicenter, randomized, double-blind, placebo-controlled parallel group, dose-ranging Phase IIb clinical trial. The Company has commenced a Phase III clinical trial of EVK-001 in female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult females. EVOKE PHARMA, INC. (NASDAQ:EVOK) Recent Trading Information
EVOKE PHARMA, INC. (NASDAQ:EVOK) closed its last trading session up +1.16 at 3.23 with 354,830 shares trading hands.