SOLANA BEACH, Calif., March 21, 2017 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty
pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company’s abstract
detailing compelling Phase 3 trial data for Gimoti™ (metoclopramide nasal spray) for the relief of symptoms associated with acute
and recurrent diabetic gastroparesis in women, was accepted for a poster presentation at Digestive Disease Week® (DDW)
2017.
The poster presentation is entitled: Symptom Severity Influences Drug Efficacy in Women with Diabetic Gastroparesis: Results
of a Phase 3 Study with Metoclopramide Nasal Spray.
“We are honored to be chosen to present the data from our Phase 3 trial for Gimoti at the upcoming DDW meeting,”
stated Marilyn R. Carlson, DMD, MD, Chief Medical Officer at Evoke Pharma. “It is an opportunity to share the benefits demonstrated
in patients with moderate to severe gastroparesis symptoms who are most in need of effective treatment. We believe the presentation
will prove valuable to scientists and clinicians who attend the meeting to learn more about the latest research and the promising
new treatments in the field of GI motility. Evoke shares their commitment to improving the quality of life and the well-being of
patients with diabetic gastroparesis.”
The lead author, Richard McCallum, MD, Professor and Founding Chair, Department of Medicine & Director of the Center for
Neurogastroenterology & GI Motility at Texas Tech University Health Sciences Center, El Paso, and a key opinion leader in
gastroparesis stated, “Patients suffering from moderate to severe gastroparesis symptoms are limited in their day-to-day activities
and require frequent interactions with the healthcare system. As a clinical researcher and treating physician, I am well aware of
the treatment options currently available and the protracted timeline for new therapies entering early phase clinical trials. These
encouraging data from Evoke’s Phase 3 trial for Gimoti, help validate the therapeutic benefits of nasal delivery of metoclopramide
and provide hope that there will be a non-oral treatment option for patients suffering from diabetic gastroparesis in the near
future.”
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 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 pharmacokinetic (PK)
trial; later developments with the Food and Drug Administration (FDA) that may be inconsistent with the already completed pre-new
drug application (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 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
