Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE) gained after presenting a poster at the 2021 SLEEP 35th Annual Meeting of the Associated Sleep Societies.
Zynerba presents a poster in ZYN002.
The poster was titled, “Impact of ZYN002 Cannabidiol Transdermal Gel on Sleep in Children and Adolescents with Developmental and Epileptic Encephalopathies and Comorbid Autism Spectrum Disorder.” It showed that in an open-label second phase study with developmental and epileptic encephalopathies (DEE) patients, Zygel treatment was linked with enhanced sleep improvement in children showing considerable sleep disorders at baseline. Most importantly, children with autism spectrum disorder (ASD) and DEE had a wide range of benefits on sleep relative to those with only DEE.
Joseph Palumbo, Zynerba’s chief medical officer, said that in people with ASD, sleep disorders and epilepsy have a bidirectional link and frequently co-occur. Therefore, changes in sleep could lead to enhanced seizure control and conduct in these high-needs children with DEE. Although the findings are preliminary, they are encouraging and should be confirmed in future Zygel clinical trials in patients with DEE or ASD.
Zyxel shows improvement in DEE patients.
Improvements in multiple elements of sleep were seen in the open-label Phase 2 trial using Zygel in patients with DEEs aged 3 to 17 years. Throughout the 26-week trial, improvements in sleep breathing, sleep-waking transition, and the total sleep disturbance scale for children were reported in patients with ASD compared to baseline. Persons without ASD demonstrated sleep initiation and maintenance improvement. In the trial, Zygel was well tolerated. The majority of treatment-related side effects were classified as mild to moderate. During the course of the 26-week trial, 60.4% of individuals experienced at least one adverse event, with 93% of those being mild or moderate in intensity.