New Data Describing Statistically Significant Results from the Phase 2 BRIGHT Trial in Patients with Autism Spectrum Disorder (ASD) Presented at the Virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CN
DEVON, Pa., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and
near-rare neuropsychiatric disorders, is presenting a poster describing data from the 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 further demonstrating the
potential for Zygel (ZYN002) to improve the core behavioral symptoms of autism when administered in addition to stable standard of care in children and adolescents with moderate-to-severe ASD.
These open label data are being presented at the virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting. These data will
also be presented as an oral presentation during the “Research Pipeline: New Findings on Diagnostic and Therapeutics” session of the virtual American Academy of Child and Adolescent Psychiatry
(AACAP) 2020 Annual Meeting on Friday, October 23rd, 2020.
A copy of the poster entitled, “Tolerability and Efficacy of ZYN002 Cannabidiol (CBD) Transdermal Gel in Children and Adolescents With Autism Spectrum Disorder: An Open-Label Phase 2 Study [BRIGHT (ZYN2-CL-030)]” is available on the Zynerba corporate website at http://zynerba.com/publications/.
“The Phase 2 BRIGHT trial provides the first clinical evidence of the potential for Zygel to improve behavioral symptomology in a group of highly symptomatic pediatric and adolescent patients with ASD,” said Helen Heussler, FRACP, Associate Professor at Children’s Health Queensland, Medical Director Child Development and principal investigator in the BRIGHT trial. “In these children receiving Zygel, the observed changes from baseline are promising. In particular, the improvements seen in core symptoms of autism, as specifically assessed by the Autism Impact Measure, are of special interest. Though open label, these results are compelling and we look forward to continuing the evaluation of Zygel in ASD in future placebo-controlled clinical trials.”
The BRIGHT Phase 2 trial is an exploratory, single-center, open-label Phase 2 study evaluating the safety and tolerability and efficacy of Zygel in children and adolescents with ASD who are 3 to <18 years old. The study enrolled patients with Clinical Global Impression (CGI)-Severity score ≥4 (moderate or greater) and Aberrant Behavior Checklist-Community (ABC-C) Irritability score ≥18. The primary objective of the trial was to evaluate the safety and tolerability of Zygel for up to 38 weeks (14-week treatment period and a 6 month extension period). Secondary objectives comprised evaluation of the efficacy of Zygel in the treatment of symptoms of ASD, including measuring parental/caregiver stress, Autism Impact Measure (AIM), and caregiver reported behavioral problems. The results provided in the poster are after 14 weeks of treatment with Zygel.
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