Evoke Pharma has announced that slower than expected enrollment in a Phase 3 clinical trial of its EVK-001 metoclopramide nasal spray for the treatment of diabetic gastroparesis in women will result in delayed completion of the development program and potential NDA submission. The company says that it now expects enrollment to be complete in the second half of 2015 and that it believes it has enough cash on hand to fund operations through the end of the year.
According to the company, only 74 patients have been enrolled so far out of 200 patients expected to enroll, “although the trial sites have been screening significant numbers of subjects.” The company blames the variability of diabetic gastroparesis symptoms and “complex medical histories” of patients for the difficulty in enrolling patients in the study and says that it has now “undertaken additional initiatives to increase enrollment to further assist clinical trial sites in the identification of eligible study subjects.”
Evoke President and CEO Dave Gonyer said, “As we work toward finalizing enrollment of our Phase 3 trial, we are identifying the appropriately qualified diabetic gastroparesis subjects in order to provide the most comprehensive data when filing our NDA. There is a significant market opportunity for a novel treatment for patients suffering from this disease, and we believe EVK-001 can provide these patients a level of therapy that the current standard of care cannot. We remain focused on the successful execution of this study and look forward to moving EVK-001 toward commercialization.”
Read the Evoke Pharma press release.
