Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, is reporting new 12-month open label clinical data describing the long term impact of ZYN002 on emotional and behavioral symptoms of Fragile X Syndrome (FXS) in a poster presentation at the 57th Annual Meeting of the American College of Neuropsychopharmacology. The presentation is taking place today from 5:30 to 7:30 PM EST in poster session III at the Diplomat Beach Resort in Hollywood, Florida. A copy of the presentation and poster are available on the Zynerba corporate website at http://zynerba.com/publications/.
In a poster entitled, “Transdermal Cannabidiol (CBD) Gel for the Treatment of Fragile X Syndrome (FXS),” Steven Siegel, M.D., Ph.D., Professor and Chair of the Department of Psychiatry and the Behavioral Sciences at the Keck School of Medicine, University of Southern California, is presenting new 12-month data from the open label Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) trial of ZYN002 in children and adolescents with FXS. The data demonstrate that treatment with ZYN002 improved core emotional and behavioral symptoms of FXS with statistical significance versus baseline across multiple measures of efficacy at month three, and that these improvements were sustained through 12 months of treatment. ZYN002 continues to be well tolerated; no serious adverse events were reported, and no clinically meaningful trends in vital signs, ECG, or clinical safety laboratories, including liver function tests, were observed.
In the Social Avoidance subscale of the Aberrant Behavior Checklist for Fragile X (ABC-CFXS), patients completing 12 months of treatment with ZYN002 experienced a 77.2% improvement in social avoidance behaviors versus baseline, compared to a 57.9% improvement at three months of treatment. Both results are statistically significant compared to baseline. The Social Avoidance subscale of the ABC-CFXS is the primary endpoint of the ongoing pivotal CONNECT-FX study of ZYN002.
“I am encouraged to see that improvements in FXS-associated emotional and behavioral symptoms after 12 months of treatment with ZYN002 are consistent with those seen at three and nine months; these data continue to suggest the potential for sustained responses that may be conserved over extended use of the drug,” said Dr. Steven Siegel of the Keck School of Medicine. “Improvements in these behaviors may enhance the child’s capacity for interaction and engagement with their peers, families, teachers and caregivers. These data are promising, and I am enthusiastic about the potential opportunity for ZYN002 in these patients. I look forward to the results of the double blind, placebo-controlled CONNECT-FX study next year.”
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