SAN DIEGO -- Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the selection of SynteractHCR, Inc. to serve as its primary contract research organization ("CRO") for its upcoming Phase 3 clinical trial of EVK-001. EVK-001 is a novel metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women with diabetes mellitus. Selection of SynteractHCR follows the successful completion of Evoke's 287 patient, multi-center Phase 2b clinical trial of EVK-001, for which SynteractHCR was the primary CRO.
Evoke is currently engaged in the Phase 3 site selection process, and is targeting approximately 60 sites in the United States, including experienced gastroparesis sites from the Phase 2b trial of EVK-001. The Phase 3 enrollment target is 200 completed patients and enrollment is expected to begin in the first half of 2014.
"We are pleased to be working with SynteractHCR on the Phase 3 trial of EVK-001 having previously worked together successfully to complete our Phase 2b trial in patients with diabetic gastroparesis. As we prepare to commence this important initiative, we believe the selection of the same CRO and the planned inclusion of many of the same Phase 2b study sites will maximize the use of our knowledge base to expedite initiation and completion of Phase3," said Dave Gonyer, R.Ph., President and CEO of Evoke Pharma. "We remain encouraged by EVK-001's clinical potential as we prepare to enter Phase 3, and are excited by its longer-term commercial prospects. We look forward to sharing additional milestones and strategic developments as we move toward launch of our Phase 3 study."
About Evoke Pharma, Inc.
Evoke Pharma 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 diabetic 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 intranasal administration.
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With its "Shared Work - Shared Vision" philosophy SynteractHCR provides customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 16 countries, SynteractHCR delivers trials internationally, offering expertise across multiple therapeutic areas.
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 negative 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 for the Phase 3 clinical trial of EVK-001, including targeted clinical sites and enrollment patient numbers and timing, and the longer-term commercial prospects 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: Evoke is entirely dependent on the success of EVK-001, which has not yet entered a Phase 3 clinical 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 planned Phase 3 clinical trial; the inherent risks of clinical development of EVK-001, including potential delays in enrollment and completion of clinical trials, including the planned Phase 3 trial; Evoke will require substantial additional funding, including to complete the planned Phase 3 clinical trial of EVK-001 as well as finance additional development requirements, and may be unable to raise capital when needed; the potential for adverse safety findings relating to EVK-001 to delay or prevent regulatory approval or commercialization; Evoke's reliance on outsourcing arrangements for many of its activities, including SynteractHCR as the primary CRO and others for clinical development and supply of EVK-001; the ability of Evoke to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidate and the ability to operate its business without infringing the intellectual property rights of others; competition from other pharmaceutical or biotechnology companies; 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.