Zynerba completes enrollment for Phase 2 BRIGHT trial of Zygel
Zynerba Pharmaceuticals announced the achievement of its enrollment target for the 14-week Phase 2 BRIGHT trial of Zygel for the treatment of pediatric and adolescent patients with autism spectrum disorder, or ASD. The Company expects to announce topline results from this study in the Q2. The 14-week exploratory Phase 2 BRIGHT trial has enrolled 36 patients with ASD at a single clinical site in Australia. The trial is designed to evaluate the efficacy and safety of Zygel in children and adolescents with ASD as confirmed by DSM-5 diagnostic criteria for ASD. Enrolled patients are receiving weight-based initial doses of 250 mg daily or 500 mg daily of Zygel. The efficacy assessments include the Aberrant Behavior Checklist, or ABC, Parent Rated Anxiety Scale - Autism Spectrum Disorder, or PRAS-ASD, Autism Impact Measure, or AIM, the Children's Sleep Habit Questionnaire (CSHQ), and Clinical Global Impression - Severity and Improvement, or CGI-S, CGI-I. After completing dosing in the 14-week period, participants may enroll in a six-month extension trial.