Epygenix Therapeutics, Inc, a precision medicine-based biopharmaceutical company, appointed GCT to conduct its potentially pivotal Phase II Dravet Syndrome clinical trial in Europe and India.
The ARGUS trial is a 20-week randomized, double-blind, placebo-controlled trial in children and adults with Dravet syndrome and begins with a 4-week Observational Phase which will establish seizure frequency and eligibility for treatment, followed by a 4-week Titration Phase. Thereafter, the participant will enter a 12-week Maintenance Phase. Patients will have the opportunity to enter a 52-week Open-Label Extension phase at the end of the Maintenance Phase. The primary objective of the study is to evaluate the efficacy of EPX-100 compared with placebo as adjunctive therapy in children and adult participants with Dravet Syndrome.
GCT is providing CRO services for the trial in six European countries, Georgia, and India, being responsible for project and site management, regulatory, clinical trial agreements negotiation, eTMF management, clinical monitoring, vendor management, GDPR, and DPO services.
Dr. Eugene Selivra, CEO said: “I am particularly delighted that GCT is selected to manage this study as we accumulated therapeutic expertise and operational ability in similar studies and will use it to achieve all the set goals. This is a critical and important trial in the path to developing a new treatment for such a rare disease”.
GCT provides an individual approach, flexible pricing, fast patient recruitment, and high-quality clinical development services for rare decease and hard-to-recruit trials, including pediatric ad adolescent studies. Contact us at bd@gctrials.com to find out more and discuss your project.