Evoke Pharma: EVK-001 Phase 3 Trial Fails To Achieve Primary Endpoint

(RTTNews) - Evoke Pharma, Inc. (EVOK) announced topline results from its Phase 3 clinical trial of EVK-001 in female patients with symptomatic diabetic gastroparesis. In the study, EVK-001, the company's patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women, did not achieve its primary endpoint of symptom improvement at Week 4. Safety results were consistent with findings from previous EVK-001 studies.

Dave Gonyer, President and CEO, said: "The topline results are unexpected and an anomaly, given that metoclopramide has been approved and used for treating diabetic gastroparesis for more than 35 years. Additionally, EVK-001 provides predictable absorption of metoclopramide as seen in our prior trials. We continue to believe that EVK-001 is a promising treatment option for patients who currently rely on oral drugs to treat their symptoms of gastroparesis. Our analysis will continue as the remainder of the data become available and an update will be provided when we have more clarity on our steps ahead."