FDA Grants Fast Track Status to SAP-001 for Treatment-Resistant Gout

FDA's decision to grant the Fast Track designation for SAP-001 was based in part on Shanton's recent efficacy and safety outcomes in a Phase 2b clinical study in which SAP-001 demonstrated the potential to meaningfully improve on currently available Urate Lowering Therapy for refractory gout patients.

About Fast Track

Fast Track is an FDA expedited review program which includes more frequent meetings with FDA, early and ongoing feedback from FDA, rolling review of NDA sections as they become available, and the possibility of priority review and accelerated approval. The purpose is to get important new drugs to patients earlier.

About SAP-001

SAP-001 is Shanton's lead investigational compound for once-a-day oral urate-lowering therapy that targets refractory gout. SAP-001's urate lowering properties are based on a unique, First-in-Class mechanism-of-action and the product has shown Best-in-Class efficacy and safety in gout patients with hyperuricemia refractory to Standard of Care Xanthine Oxidase Inhibitor therapy in a recent Phase 2b study.