Evoke Pharma said today that its lead candidate EVK-001 failed a Phase III trial by missing its primary endpoint of improving symptoms associated with acute and recurrent diabetic gastroparesis in adult women following 4 weeks of treatment.
EVK-001, Evoke’s patented metoclopramide nasal spray, showed similar improvement with placebo following a preliminary review of topline data across all study sites.
Results were measured using a proprietary Patient Reported Outcome (PRO) instrument that was used to calculate a weekly score based on daily telephone diary entries by study subjects who reported the frequency and severity of their gastroparesis signs and symptoms.
The trial measured a total symptom score as well as individual scores for each sign and symptom, Evoke said, adding that results were not consistent across the study sites.
“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,” Evoke President and CEO Dave Gonyer, R.Ph., said in a statement. “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.”
Gonyer said the company will continue its analysis as the remainder of the data becomes available: “An update will be provided when we have more clarity on our steps ahead.”
Evoke has spoken publicly of advancing commercial preparation of EVK-001 as recently as July 7, when it entered into a master service agreement with inVentiv Commercial Services designed to build its commercial infrastructure in preparation for the filing of an NDA with the FDA. The agreement allowed inVentiv to provide services including, but not limited to, sales representatives, sales management, marketing, account management, advertising, medical communications, distribution support, and overall commercial management.
The Phase III study was a U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy, safety, and population pharmacokinetics of EVK-001 in 205 adult female subjects with diabetic gastroparesis who received EVK-001 or placebo four times daily for four weeks.
Evoke said safety results were consistent with findings from past EVK-001 studies, which showed that the nasal formulation of metoclopramide has a favorable safety profile and is well-tolerated by healthy volunteers and patients with diabetic gastroparesis.
The Phase III study generated “slightly” more reports of nasal irritation in patients receiving placebo compared with patients receiving EVK-001, Evoke said.