Zynerba Pharmaceuticals Announces Positive Top Line Results from Exploratory Open Label Phase 2 BRIGHT Trial of Zygel in Autism Spectrum Disorder

- The BRIGHT Trial Achieved Statistically Significant and Clinically Meaningful Improvements from Baseline in All Subscales of the Aberrant Behavior Checklist -

- Safety Data Reinforce Excellent Tolerability Profile of Zygel -

- Zynerba to host conference call and webcast today, May 27, 2020 at 8:30 am ET -

DEVON, Pa., May 27, 2020 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced positive top line results from the exploratory, open label Phase 2 BRIGHT (An Open-Label Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Autism Spectrum Disorder) trial.

The trial was designed to assess the safety, tolerability and efficacy of Zygel in pediatric and adolescent patients with autism spectrum disorder (ASD). Zygel was administered to patients with moderate-to-severe symptoms of ASD as add-on therapy to their standard of care utilizing a variety of efficacy assessments. Key findings from the trial disclosed today include:

• All five subscales of the Aberrant Behavior Checklist – Community (ABC-C) as well as the Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS-ASD) showed both statistically significant and clinically meaningful improvements at 14 weeks of treatment from baseline;
• The results observed in other efficacy outcome measures, including Clinical Global Impressions - Improvement scale (CGI-I), support the subscale results observed in the ABC-C;  
• Zygel was well tolerated in this trial with no serious or severe adverse events reported.

“We are very encouraged by the compelling top line results of the BRIGHT trial and we expect to meet with the FDA to discuss the clinical pathway for developing Zygel for the treatment of behavioral symptoms of ASD in the second half of this year,” said Armando Anido, Zynerba’s Chairman and Chief Executive Officer. “Our goal is to develop Zygel for patients suffering from debilitating neuropsychiatric disorders including ASD, Fragile X syndrome, 22q and DEE. I want to thank the patients, families, physicians, clinical staff, and the Zynerba team for their support of this key study in ASD."