Shanton Pharma, a China-based, clinical-stage biotech developing a novel treatment for hyperuricaemia and gout in adults, announced on Wednesday that it has reached an agreement with the European Medicines Agency (EMA) on a Paediatric Investigation Plan for Shanton's lead investigational product, SAP-001.

The EMA has agreed to a product-specific full waiver in all paediatric age subsets with hyperuricaemia of any cause other than chronic kidney disease or obesity. This waiver follows that of the agreed initial Paediatric Study Plan filed with the US Food and Drug Administration (FDA) in May of this year, which exempts SAP-001 from paediatric study requirements due to the extremely low prevalence of gout in children.

SAP-001 is Shanton's lead investigational compound for once-a-day oral urate-lowering therapy that targets uncontrolled/refractory gout. The company says that SAP-001's urate lowering properties are based on a unique, First-in-Class mechanism-of-action, and the program 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.

Last year, Shanton received FDA's Fast Track designation for SAP-001, based in part on its recent Phase 2b results demonstrating the drug's potential to meaningfully improve on currently available Urate Lowering Therapy for patients with uncontrolled/refractory gout, a serious condition for which there are considerable unmet medical needs.