Shanton Pharma, a China-based, clinical-stage biotech developing a novel treatment for gout, announced on Monday that it has completed an End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) for its Investigational New Drug SAP-001 for the treatment of hyperuricemia with gout in adult patients who are refractory to conventional therapy.

SAP-001 is the company's lead investigational compound for once-a-day oral urate-lowering therapy that is aimed at refractory gout. Earlier this year, it received Fast Track designation from the FDA based in part on Phase 2b results demonstrating the drug's potential to meaningfully improve upon currently available urate-lowering therapy for patients with refractory gout.

Dr. Bing Li, Shanton's CEO, said: "This End-of-Phase 2 meeting is a crucial milestone for our refractory gout programme as it provides alignment with FDA on our upcoming Phase 3 pivotal programme, including protocol, trial design, patient population, dose selection, proposed endpoints, and statistical analysis methods. Based on FDA's feedback we are confident to enter into a Multi-Regional Clinical Trial programme in the coming months, aiming to offer a much-needed solution for uncontrolled gout patients."