Evoke Pharma, Inc. has announced topline results from its Phase 3 clinical trial of EVK-001 in female patients with symptomatic diabetic gastroparesis. In this 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.
Preliminary review of topline data across all study sites revealed similar improvement in the EVK-001 and placebo groups at Week 4 as measured by the total symptom score as well as the individual scores for each of the signs and symptoms, but these results were not consistent across the study sites. Further evaluation of topline data revealed diary data from 28 of 41 of the enrolling sites showed a statistically-significant benefit at Week 4 for EVK 001 (p=0.006) in contrast to results from the other 13 sites that showed statistically significant benefit for placebo (p=0.002). Once the complete datasets and PK data are available, additional analyses will be conducted to further understand the discrepant results.
Safety results were consistent with findings from previous EVK-001 studies that showed the nasal formulation of metoclopramide has a favorable safety profile and is well-tolerated by healthy volunteers and patients with diabetic gastroparesis. In this Phase 3 study, there were slightly more reports of nasal irritation in subjects receiving placebo than in subjects receiving EVK-001.
The study was a U.S.-based, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy, safety and population pharmacokinetics (PK) of EVK-001 in 205 adult female subjects with diabetic gastroparesis who received EVK-001 or placebo four times daily for four weeks. The primary endpoint was the change in symptoms from the baseline period to Week 4 as measured using a proprietary Patient Reported Outcome (PRO) instrument. The PRO 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 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," stated Dave Gonyer, R.Ph., President and CEO. "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."