Shares of Evoke Pharma (NASDAQ: EVOK) are 35% higher in morning trade after the company reported positive data from its phase 3 trial of Gimoti for symptomatic relief of acute and recurrent diabetic gastroparesis. While the study failed to reach its primary endpoint, Gimoti “significantly” reduced nausea and abdominal pain in moderate to severe patients. Evoke notes that the results are consistent with FDA guidance on the clinical evaluation of drugs used to treat gastroparesis. “As our discussions with the FDA progressed over the past few months, we have continued to analyze data from our Phase 3 trial of Gimoti … Among the more significant outcomes from these analyses was the statistically significant and clinically meaningful improvement in symptom scores in moderate and severe patients which consisted of a large portion of the overall study population. In this group, those treated with Gimoti reported significantly better results than those who received placebo with benefits seen as early as study week one. It is also important to note that nausea and abdominal pain, two of the more severe and common symptoms of gastroparesis, showed the most improvement in patients receiving Gimoti. These symptom benefits were also observed in our Phase 2B trial,” Evoke president and CEO Dave Gonyer, R. Ph., stated in the news release.
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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. For more information visit www.evokepharma.com
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