Spinogenix Announces U.S. FDA Approval of its Investigational New Drug Application for its Phase 2a Clinical Trial of SPG601 for Fragile X Syndrome
SPG601 works by restoring synaptic function to address core symptoms of FXS.
- SPG601 works by restoring synaptic function to address core symptoms of FXS.
- The Phase 2a trial will evaluate the neurophysiological and clinical effects of single-dose SPG601 and placebo in adult men with FXS.
- SPG601 is a novel small molecule BK channel activator that works by binding to BK channels and increasing their activation to restore synaptic function.
- We look forward to the first study of a BK channel modulator in humans with Fragile X and taking the first step to evaluate this important drug mechanism in Fragile X Syndrome.”