Marinus Announces Completion of Marigold Trial
Marinus Pharmaceuticals Completes Targeted Enrollment in Pivotal Phase 3 Study for CDKL5 Deficiency Disorder
“Enrolling 100 patients in our registrational, pivotal Phase 3 trial evaluating ganaxolone in
children with CDD is a significant milestone for both Marinus and the CDD community,” said
Joe Hulihan, M.D., Chief Medical Officer of Marinus. “Our ability to identify and rapidly enroll qualified patients into this study is indicative of the significant need for a new therapy to reduce seizure burden and improve patient outcomes. The study has been well conducted and we are encouraged by the limited adverse events, low dropout rates and the vast majority of patients entering the open-label extension. We are appreciative of the patients and broader CDD community for their participation in the Marigold study and we remain committed to addressing the unmet need of these patients who currently have no approved treatment options.”
Karen Utley, President of the International Foundation for CDKL5 Research, commented, “We
are grateful for Marinus’ recognition of the tremendous need of children with CDD and its
dedication to advancing the development of ganaxolone as a potential new treatment for these
children through the Marigold study. We are proud of our collaborative partnership to lead the way in finding a cure and treatments for children with CDD and are hopeful that ganaxolone may be a novel treatment option that improves outcomes for our children.”