EMA approves Oryzon's application for Phase II HOPE-2 study

The EMA has approved Oryzon Genomics’ CTA to begin the Phase II HOPE-2 study of vafidemstat in patients with Phelan-McDermid syndrome (PMS). The single-arm, single-centre, open-label trial will evaluate vafidemstat in 12 adult patients in Spain. Phelan-McDermid syndrome is a genetic neurodevelopmental disorder stemming from SHANK3 gene deletions or mutations. Credit: luchschenF / Shutterstock.com. The European Medicines Agency (EMA) has approved Oryzon Genomics’ clinical trial application (CTA) to begin the Phase II HOPE-2 study of vafidemstat in patients with Phelan-McDermid syndrome (PMS). The single-arm, single-centre, open-label trial will evaluate the therapy in 12 adult patients in Spain. LOA and PTSR…

Source: Clinical Trials Arena