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Evoke Successfully Completes Phase 3 Clinical Trial Enrollment of EVK-001 in Women with Symptoms Associated with Diabetic Gastroparesis

Evoke Pharma, Inc. EVOK, +1.05% today announced that it has successfully completed patient enrollment in its pivotal 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.

The four-week, U.S. multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial is evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in approximately 200 adult female subjects with diabetic gastroparesis. The primary endpoint is the change from baseline in symptom score at week 4 utilizing a proprietary Patient Report Outcome (PRO) instrument.

"Completing enrollment of our Phase 3 clinical trial of EVK-001 is a monumental step for Evoke, and based on discussions with the FDA, this pivotal trial is the final study necessary to submit a New Drug Application (NDA)," said Dave Gonyer, R.Ph., President and CEO. "We remain confident in the success of our Phase 3 trial based on the positive results from our large Phase 2b study which demonstrated safety and statistically significant symptom improvement in women, who make up 80% of all patients with gastroparesis."

Mr. Gonyer continued, "While completing enrollment in the Phase 3 clinical trial, we have been preparing to submit an NDA as soon as possible, should the results of the study be positive. Importantly, we completed a Thorough ECG (TQT) study, which demonstrated that therapeutic and supratherapeutic doses of EVK-001 did not adversely affect the QT interval in healthy subjects, and we have produced EVK-001 at commercial scale in accordance with the FDA standards for chemistry, manufacturing and controls. These data will be submitted as part of our NDA package. This is a very exciting time for Evoke as our strategic...