SOLANA BEACH, Calif., May 24, 2016 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that data from its successful thorough electrocardiogram (ECG) study of EVK-001, its patented nasal delivery formulation of metoclopramide for the treatment of symptoms associated with acute and recurrent diabetic gastroparesis in women, were presented at Digestive Disease Week (DDW) 2016.
“As we prepare our New Drug Application (NDA) for submission to the FDA, acceptance of our TQT study for presentation at DDW provides further recognition of the importance of EVK-001 safety information to clinicians that specialize in the treatment of challenging gastrointestinal disorders, such as gastroparesis,” stated Marilyn R. Carlson, DMD, MD, Chief Medical Officer. Study results showed that EVK-001 did not increase the time the heart's electrical system takes to repolarize after each beat and did not demonstrate consistent ECG changes at 8 times the dosage level that is proposed to be marketed.
Evoke designed the study in accordance with published FDA and ICH guidance on the clinical evaluation of QT/QTc interval prolongation and the proarrhythmic potential of non-cardiac drugs. The QT interval represents the amount of time the heart's electrical system takes to repolarize, or recharge, after each beat, and prolongation of the interval may increase the risk for cardiac arrhythmias. The randomized, double-blind, double-dummy, four-way crossover study investigated the effects of therapeutic and supratherapeutic doses of EVK-001 on the QT/QTc interval in 48 healthy female and male volunteers.
The Company recently completed enrollment in its phase 3 clinical trial of EVK-001 for treatment of symptoms associated with diabetic gastroparesis in women. Data from this trial are expected early in the third quarter of 2016. Evoke expects the data to enable it to move forward with its NDA submission.
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 EVK-001, 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. EVK-001 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 timing of data from the Phase 3 clinical trial of EVK-001; the sufficiency of such data and the other activities completed to data providing a basis for the submission of an NDA for EVK-001 to the FDA; and the potential commercialization and marketing plans for EVK-001. 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 risk and uncertainties inherent in Evoke's business, including, without limitation: the inherent risks of clinical development of EVK-001 and completion of the Phase 3 trial as well as potential delays in any other clinical trials and studies; Evoke is entirely dependent on the success of EVK-001, and Evoke cannot be certain that it will be able to obtain regulatory approval for EVK-001; the results observed in female patients with symptoms associated with acute and recurrent diabetic gastroparesis in Evoke's Phase 2b clinical trial of EVK-001 may not be predictive of the safety and efficacy results in the Phase 3 clinical trial; Evoke will require substantial additional funding to potentially commercialize EVK-001 as well as to finance additional development requirements, and may be unable to raise capital when needed, including to fund ongoing operations; the potential for adverse safety findings relating to EVK-001 to delay or prevent regulatory approval or commercialization; Evoke may not be able to successfully commercialize EVK-001, 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.
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