As Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) head into 2018, the management look forward to delivering on several significant clinical and corporate milestones that are vital to their investors and the patients they plan to treat. They consider 2018 as a period of corporate evolution for company.
Zynerba plan to initiate a pivotal trial for ZYN002 in FXS that is expected to read out in 2019, commence two new Phase 2 trials in refractory epilepsies, and begin a Phase 2 plan with ‘ZYN001’ in Tourette Syndrome. The company will continue to collect a considerable amount of important statistics from its ongoing open-label extension trials in adult refractory focal epilepsy and Fragile X syndrome that they expect to publish and/or present during the year.
Zynerba is currently advancing ZYN002, the first and single patent-based, pharmaceutically-produced Cannabidiol that is made as a permeation-enhanced gel targeting transdermal delivery. The firm has a meeting scheduled with the USFDA during Q1 2018 to discuss development plan counting a pivotal clinical plan for ZYN002 in Fragile X Syndrome, an inherited autism spectrum problem affecting around 71,000 patients in the United States. The firm projects to commence the major, double-blind placebo regulated clinical study mid-year 2018. Zynerba Pharmaceuticals has received Orphan Drug designation in the U.S. for the application of Cannabidiol as treatment of FXS.
The firm projects to begin an open-label trial of ZYN002 in DEE, a category of ultra-rare and rare, severe brain problems manifesting with EEG abnormalities or seizures that can worsen behavior or cognition. The study will commence in 1H2018 and will enroll around 48 adolescent and pediatric patients. It is intended to list new indications to advance into blinded, placebo-controlled trials.
Zynerba plans to commence a Phase IIB double-blind placebo regulated clinical study of ‘ZYN002’ in adult refractory focal epilepsy. The company is evaluating ZYN002 potential in other near-rare as well as rare neuropsychiatric indications.