Spinogenix Granted FDA Orphan Drug Designation for SPG302 for the Treatment of Amyotrophic Lateral Sclerosis

Spinogenix, Inc. a pharmaceutical company focused on the development of novel synaptogenic small molecule therapies for central nervous system disorders and rare diseases, today announced it has been granted Orphan Drug Designation (ODD) for SPG302 in amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) by the U.S. Food and Drug Administration (FDA). By obtaining orphan drug designation, SPG302 is now eligible for such benefits as exemption from FDA user fees and tax credits for clinical research.

In addition, Spinogenix reports the successful completion of pre-IND (Investigational New Drug) interaction with the FDA regarding the current development plan for SPG302. The FDA agreed to the overall development program including the first-in-human Phase 1/2 clinical study in ALS patients followed by a Phase 2/3 Pivotal trial based on safety/PK/biomarker data.

“Receiving orphan drug designation from the FDA for the treatment of ALS is an important milestone,” stated Stella Sarraf, Founding CEO at Spinogenix. “We are also pleased with the guidance from the FDA that now provides us with a clear clinical plan to rapidly advance our first-in-class drug to help ALS patients.”

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