Harmony Biosciences announces RECONNECT study did not meet primary endpoint

Harmony Biosciences (HRMY) announced topline results from its Phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome. The RECONNECT study did not meet the primary endpoint of improvement in social avoidance primarily due to a higher-than-expected placebo response rate. The RECONNECT Study was a Phase 3 randomized, double-blind, placebo-controlled, multiple-center study, to assess the efficacy and safety of ZYN002, a pharmaceutically manufactured cannabidiol administered as a transdermal gel to patients with FXS ages three to under 30 years old. Kumar Budur, chief medical and scientific officer at Harmony Biosciences said, “Although the study did not achieve its primary endpoint, the findings from this study provide valuable insights into Fragile X syndrome, a rare neurobehavioral condition with significant unmet medical need and no FDA-approved therapies. We will conduct a comprehensive analysis of the full dataset to better understand the results as part of our continued commitment to the Fragile X community.” Budur added, “We are grateful to the patients, families, caregivers, clinicians, and researchers who made this trial possible.”