Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout,  announced that FDA has designated its Investigational New Drug SAP-001 as a Fast Track product for treatment of hyperuricemia in adult patients with gout who are refractory to conventional therapy.

"We are excited about the Fast Track designation for SAP-001" says Dr. Wenfeng Miao, Shanton's CMO. "Refractory gout is a serious condition for which there are considerable unmet medical needs, requiring the development of new treatments. We are pleased to tap into the opportunity for faster regulatory reviews provided by this designation to speed up the availability of a much-needed solution for gout patients who do not respond to or cannot tolerate Standard-of-Care treatment with conventional Urate Lowering Therapies."

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.