Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) revealed positive top line results from the exploratory, open label Phase 2 INSPIRE trial. Based on the positive Phase 2 data, the company will request a meeting with the U.S. Food and Drug Administration to discuss the data and the regulatory path forward.
The Phase 2 trial was designed for signal detection by assessing the safety, tolerability and efficacy of Zygel (also known as ZYN002) for the treatment of behavioral symptoms of chromosome 22q11.2 deletion syndrome (22q) in children and adolescents. Zygel was administered to patients with 22q as add-on therapy to their standard of care and utilized a variety of efficacy assessments. Key findings from the trial include:
