(Reuters) – Zynerba Pharmaceuticals Inc said on Tuesday its experimental cannabis-based gel Zygel was not statistically significant in improving aberrant behavior when compared to a placebo in patients with a neurological disorder called Fragile X syndrome.
The company’s shares plunged 48.5% to $3.37 before the opening bell.
The drug, which also did not meet secondary goals of the 212-patient study, is a synthetic version of cannabidiol – a component of the cannabis plant.
The company said a pre-planned analysis of patients most severely impacted by the disease did show statistically significant improvement in behavior at week 12.
Based on the data, Zynerba plans to meet with the U.S. Food and Drug Administration for a path forward for Zygel.
Fragile X syndrome (FXS) is characterized by mild-to-moderate intellectual disability.
Reporting By Mrinalika Roy and Manas Mishra in Bengaluru; Editing by Maju Samuel