SOLANA BEACH, Calif., March 01, 2016 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today provided an update on enrollment of its ongoing Phase 3 clinical trial of EVK-001, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women. Additionally, the Company has amended a covenant associated with timing of Phase 3 data results under its $4.5 million loan and security agreement (the credit facility) with Pacific Western Bank (as successor to Square 1 Bank).
“As of today, we have enrolled 186 subjects, or 93%, of the 200 subjects needed to complete our four-week, multicenter, randomized, double-blind, placebo controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy and safety of EVK-001 in women with symptoms associated with diabetic gastroparesis. Based on enrollment trends we have seen at our trial sites, we believe the remaining subjects will be randomized in the near term,” said Dave Gonyer, R.Ph., President and CEO.
Mr. Gonyer continued, “In addition to the positive enrollment progress, Pacific Western Bank and Evoke have agreed to extend the deadline under the credit facility to September 30, 2016 to report Phase 3 data results. We expect our current funding to support our operations through October 2016 and past the reporting of Phase 3 data results. We are steadily advancing the clinical and regulatory development of EVK-001 and have begun preparing for potential commercialization in order to bring a much needed treatment option to market for the millions of women who suffer from diabetic gastroparesis.”
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 sufficiency of Evoke’s cash resources to fund operations through October 2016; the enrollment completion of Evoke’s ongoing Phase 3 clinical trial of EVK-001 and the timing of data from the trial; and the potential commercialization of 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, including delays in enrollment 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, for which it has commenced a Phase 3 clinical trial and male companion trial, and Evoke cannot be certain that it will be able to obtain regulatory approval for, or successfully commercialize, 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 spend its available cash faster than it anticipates; Evoke may fail to comply with the affirmative and negative covenants under the credit facility; 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.
CONTACT: Investor Contact: The Ruth Group David Burke Tel: 646-536-7009 dburke@theruthgroup.com Media Contact: The Ruth Group Kirsten Thomas Tel: 646-536-7014 kthomas@theruthgroup.com
