Fragile X syndrome is a rare genetic developmental disability that is the leading known cause of both inherited intellectual disability and autism spectrum disorder, affecting 1 in 3,600 to 4,000 males and 1 in 4,000 to 6,000 females. 10,758,497, titled “Treatment of Fragile X Syndrome with Cannabidiol” which includes claims directed to a method of treating FXS comprising administering 250mg or 500mg of synthetic or purified cannabidiol in a pharmaceutically acceptable carrier to a person in need thereof. The data in the poster show that the statistically significant improvements from baseline that were observed at week 12 were sustained in each subscale score of the Aberrant Behavior Checklist for Fragile X (ABC-CFXS) through two years for patients who participated in the open label extension. On behalf of the entire Zynerba team, I want to sincerely thank the patients, families and investigators who participated in this study as well as the National Fragile X Foundation, the FRAXA Research Foundation, and the Fragile X Association of Australia for their assistance in this study.”. Safety and TolerabilityZygel was very well tolerated, and the safety profile was consistent with previously released data from other Zygel clinical trials. “We appreciate our partnership with the FDA, and thank them for their input and support as we seek to advance the development of Zygel in certain rare epilepsy syndromes,” continued Anido.
Mean Percentage of Improvements from Baseline in ABC-CFXS Subscale Scores, Patients Who Entered Period 2. Improved cognition/concentration: 47% (n = 20), Improved socially avoidant behaviors: 44% (n = 19), Improvement in irritability: 33% (n = 14). Devon, PA, May 26, 2020 – Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, is presenting two posters on the safety, efficacy and quality of life results of the Phase 2 BELIEVE (Open Label Study to Assess the Safety and Efficacy of Zygel™ (ZYN002) Administered as a Transdermal Gel to Children and Adolescents with Developmental and Epileptic Encephalopathy) clinical trial. Two hundred and forty-five (245) patients with Fragile X syndrome, confirmed with the full mutation of the FMR1 gene, were enrolled at 21 clinical sites in the United States, Australia, and New Zealand. A copy of today’s presentation will be made available prior to the time of presentation on the Zynerba corporate website at http://zynerba.com/publications/. The multi-national, randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of Zygel™ CBD gel as a treatment in for behavioral symptoms of Fragile X syndrome (FXS) in 212 patients. Proportion of Patients with a ≥50% Improvement from Baseline ABC-CFXS Subscales for (A) Patients Who Completed Period 1 and (B) Patients Who Entered Period 2, Evidence of Global, Multi-domain, and Sustained Reduction in Behavioral Symptom Burden.
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