On September 24, 2025, Harmony announced that Zygel, a synthetic cannabidiol, missed the primary endpoint in its pivotal Fragile X trial. While the outcome was disappointing for many families in the Fragile X syndrome (FXS) community, it advanced understanding of the condition and reinforced the importance of early, quantitative clinical studies.
In this discussion, Spinogenix CEO Stella Sarraf, PhD, and Chief Medical Advisor Craig Erickson, MD, reflect on Harmony’s findings and share why they remain optimistic about the development path and progress of SPG601. Spinogenix’s first-in-class therapeutic tablet works at the synaptic level, targeting a well-established molecular dysfunction in FXS, to improve core symptoms and challenging behaviors, which can include severe anxiety, social aversion, hyperactivity and attention deficit, sensory hypersensitivity, aggression and others. The hope is that this novel approach will enhance the overall quality of life for people living with FXS.