Spinogenix announced results from its Phase 2 study of SPG601, showing a strong efficacy signal in improving abnormal brain activity in Fragile X syndrome (FXS). Presented at the NIH Fragile X Centers of Excellence Conference, the study demonstrated that SPG601 significantly reduced high-frequency gamma band activity, a key marker of brain dysfunction in FXS.

Dr. Craig Erickson, Spinogenix’s Chief Medical Advisor and principal investigator at Cincinnati Children’s, highlighted the significance of these findings, stating that the results with this metric are the most profound he has ever seen in Fragile X research.

SPG601 offers a new therapeutic approach for FXS at a time when there are no approved treatments. The FDA has granted SPG601 both Orphan Drug and Fast Track designations, expediting its development.

Watch the video below to learn more about this breakthrough | https://fragilex.org/webinar/2025-nih-fragile-x-centers-of-excellence-webinar/.

Spinogenix and Cincinnati Children’s are preparing these data and other study findings for publication.