Spinogenix, a biopharmaceutical company, has announced the initiation of the CLARITY trial, a Phase 2b/3 clinical study evaluating SPG601 for the treatment of Fragile X syndrome. The announcement was made on April 24, 2026, according to a press release from the company.
Fragile X syndrome is a genetic condition that causes intellectual disability, behavioral challenges, and learning difficulties. It is the most common inherited cause of intellectual disability and the leading known genetic cause of autism spectrum disorder.
SPG601 is an oral small molecule designed to normalize synaptic function in the brain. The CLARITY trial is a randomized, double-blind, placebo-controlled study that will assess the safety and efficacy of SPG601 in adolescent and adult patients with Fragile X syndrome.
The study is expected to enroll approximately 200 participants at multiple clinical sites in the United States and Australia. The primary endpoint is the change from baseline in the Aberrant Behavior Checklist-Community Edition (ABC-C) Social Avoidance subscale score.
Spinogenix has received Orphan Drug Designation from the U.S. Food and Drug Administration for SPG601 for the treatment of Fragile X syndrome. The company plans to report top-line data from the CLARITY trial in the second half of 2027.
