The Devon, Pennsylvania-based company said in a release earlier this week that it expects the results in the second half of 2019. Fragile X is a genetic condition that leads to learning disabilities and attention deficit disorder.
Shares of Zynerba were trading in a narrow range and recently changed hands at US$3.67 in Wednesday’s Nasdaq trading.
Zynerba has completed enrollment for its Phase 2 clinical trial of the ZYN002 transdermal gel’s use on children and adolescents with developmental and epileptic encephalopathy. Top-line results of that study are due to be reported in the third quarter of 2019.
“Our aspirations and expectations are clear: to work closely with the US Food and Drug Administration to expand the opportunity for pharmaceutically developed cannabidiol treatments that meet its rigorous medical and manufacturing standards, and in doing so, continue toward our goal of addressing significant unmet medical needs in neuropsychiatric disorders,” CEO Armando Anido said in a statement.
Zynerba added that it has expanded its pipeline with the addition of two new childhood neuropsychiatric clinical targets for the cannabidiol gel: autism spectrum disorder and 22q deletion syndrome, a rare genetic syndrome leading to neuropsychiatric disorders.
The company expects to initiate Phase 2 studies in the first half of 2019 and report top-line results in the first half of 2020.
Zynerba said it has postponed the start of its clinical trial for adult epilepsy and added that it expects to have sufficient cash through the second half of 2020.
Contact Dennis Fitzgerald at firstname.lastname@example.org