SOLANA BEACH, Calif., April 28, 2014 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that data from the Company's Phase 2b clinical trial of EVK-001, a novel intranasal formulation and delivery method of metoclopramide for diabetic female patients with symptoms associated with gastroparesis, was accepted for an oral presentation at Digestive Disease Week 2014 (DDW). DDW will take place May 3-6, 2014 in Chicago, Illinois.
The multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging Phase 2b study evaluated the efficacy and safety of metoclopramide nasal spray in patients with symptoms associated with acute and recurrent diabetic gastroparesis when dosed four times a day for 28 days. Henry P. Parkman, M.D., Director of the GI Motility Laboratory at the Temple University School of Medicine, will be presenting the data at DDW on Saturday, May 3, 2014.
Dr. Parkman commented, "The results of this large Phase 2b clinical trial were encouraging and quite unexpected. In this large study, metoclopramide nasal spray provided a significant clinical benefit in reducing the symptoms of diabetic gastroparesis in women, while in men, it did not. Since more than 80% of patients with diabetic gastroparesis are female, this is important new information that I look forward to presenting at this year's Digestive Disease Week. Metoclopramide nasal spray has the potential to address an unmet need for patients who are suffering from this disease."
Marilyn R. Carlson, D.M.D., M.D., Chief Medical Officer of Evoke, added, "One of the major challenges in treating patients with gastroparesis is to ensure adequate drug absorption even when they are experiencing symptom flares. EVK-001 delivers metoclopramide as a nasal spray which may provide predictable absorption regardless of symptoms and gastric emptying delays. These Phase 2b data represent an important step in addressing the need for more effective management of symptoms for women with diabetic gastroparesis. We believe Digestive Disease Week is an excellent forum through which to present these clinical research findings to scientists and physicians."
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 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.
Safe Harbor Statement
Evoke cautions you that statements included in this press release or the presentation at DDW 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 the potential for EVK-001 to address an unmet medical need. 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 or the presentation due to the risk and uncertainties inherent in Evoke's business, including, without limitation: the inherent risks of clinical development of EVK-001, including potential delays in enrollment and completion of clinical trials, including the ongoing Phase 3 clinical trial; Evoke will require substantial additional funding, including potentially to complete the Phase 3 clinical trial of EVK-001 as well as finance additional development requirements, and may be unable to raise capital when needed; 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 or any other future trial; 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 clinical development and supply of EVK-001; 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.