DEVON, PA — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) announced that the Company recently revised its target for reporting topline results from the pivotal Phase 3 RECONNECT trial of Zygel in Fragile X syndrome (FXS). The Company now expects topline results in the first half of 2024, rather than the second half of 2023.
The impact of environmental factors including unusually high rates of RSV (respiratory syncytial virus) and influenza and the continued impact of COVID-19 among children, adolescents, family members, and investigational center personnel, has resulted in higher than expected cancellations of initial screening visits at the investigational centers which has led to slower than anticipated enrollment. Despite these issues, clinical investigators at the 27 sites in the U.S., Australia, the UK and Ireland remain committed to completing the trial.
“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,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “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.”
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