Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) has revised its timeline for releasing topline results from its multiple-centre Phase 3 RECONNECT trial, which sees Zygel administered to children and adolescents aged from three to 17 to treat symptoms of Fragile X syndrome (FXS).
The pharma group said factors including the so-called 'Tripledemic' (high rates of respiratory syncytial virus (RSV), influenza and COVID-19) had led to higher-than-expected cancellations of initial screening visits at the trial's investigational centers, leading to slower-than-anticipated enrollment.
The company said it now expects topline results in the first half of 2024, rather than the second half of 2023.
"Though we are still striving to report topline results by the end of 2023, when we look at the current and projected impact of the Tripledemic, we believe that the first half of 2024 is a more reasonable timeframe to have topline results from RECONNECT," Armando Anido, the CEO of Zynerba told investors in a statement.
"We have also prioritized our corporate business plans to focus almost exclusively on completing RECONNECT and now expect we have cash into mid-year 2024."
READ: Zynerba Pharmaceuticals announces positive long-term data from Phase 2 INSPIRE trial at annual meeting of the American College of Neuropsychopharmacology
RECONNECT is a randomized, double-blind, placebo-controlled, multiple-center efficacy and safety trial of Zygel for FXS. Despite these issues, clinical investigators at the 27 sites in the US, Australia, the UK and Ireland remain committed to completing the trial, noted Zynerba.
Zygel is the first and only pharmaceutically-manufactured cannabidiol formulated as a clear gel, designed to provide controlled drug delivery into the bloodstream transdermally - namely through the skin.
The gel is being advanced for the potential treatment of behavioral symptoms associated with FXS, 22q11.2 deletion syndrome (22q) and autism spectrum disorder (ASD).
Zynerba has received orphan drug designation for cannabidiol, the active ingredient in Zygel, from the US Food and Drug Administration (FDA) and the European Commission in the treatment of FXS and the treatment of 22q.
Zygel has also been designated a Fast Track development program for treatment of behavioral symptoms of FXS.
Contact the author at giles@proactiveinvestors.com