Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) has released 12-month clinical data that describes the lifelong impact of ZYN002 on developmental and responsive symptoms of Fragile X syndrome. In a poster for the presentation in the 57th annual meeting, Professor Steven Siegel gives the presentation of the 12-month data of the second phase of the clinical trial of ZYN002 on FXS in children and teenagers. Results indicate that ZYN002 is tolerant regarding response and there are no adverse effects that have been reported in trials.
Improvement of FXS
According to Siegel, he was encouraged to witness improvements in FXS associated developmental and responsive symptoms after 12 months under ZYN002 treatment. He adds that their improvement in social avoidance behaviours among children showed consistency and therefore the data suggested that the possible responses towards the drug may be extended. He indicated that the improvement shows how they have progressed in the development of ZYN002 and that the data provided insight into the potential of ZYN002 among FXS patients. There are expectations that they are likely to have a double-blind sample controlled CONNECT-FX study in 2019.
Zynerba has also released updates on clinical progress, and the company is hopeful that lit is on track to report on the CONNECT-FX study by June 2019. The company has also completed the second phase of the BELIEVE 1 trial in epileptic and developmental encephalopathies in children and adolescents with full results expected in the third quarter of next year. However, the company announced that it is postponing the adult epilepsy clinical trials until after the childhood neuropsychiatric investigations are completed.
The CEO and Chairman, Armando Anido, indicated that the company’s ambition and expectations were on course and that they were working closely with the FDA to expand into CBD pharmaceuticals that meet the demanding medical manufacturing principles. The expectation is that they want to continue to address the high number of unmet medical requirements, especially in neuropsychiatric disorders. In addition to DEE and FXS, the new ASD and 22q indications are expected to be of great significance in the transdermal gel of ZYN002 which will be critical in patients without other therapeutic options.