Evoke Pharma announced topline Phase 3 data demonstrating that treatment with EVK-001 for the symptomatic relief of acute and recurrent diabetic gastroparesis in adult women failed to achieve the primary endpoint at Week 4.
The Phase 3 study was a randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and population pharmacokinetics of EVK-001 in 205 adult women with diabetic gastroparesis. Patients either 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, a tool used to calculate a weekly score based on the reported frequency and severity of gastroparesis signs and symptoms.
Preliminary study results showed that patients treated with EVK-001 and placebo had similar improvements in gastroparesis symptom frequency and severity at Week 4, however, results were inconsistent across study sites. Further evaluation of the data revealed that 28 of the 41 sites showed a statistically significant benefit for EVK‑001 (P=0.006) at Week 4, in contrast to the other 13 sites that showed statistically significant benefit for placebo (P=0.002). Additionally, the study showed that EVK‑001 has a favorable and tolerable safety profile which is consistent with findings from previous studies. The company will conduct additional analyses of the study once the complete datasets are available.
EVK-001 is a novel formulation of metoclopramide designed to provide systemic delivery through nasal administration.
For more information visit Evokepharma.com.