Shanton Pharma Completes EOP2 Meeting with US FDA for Refractory Gout Program

"This End-of-Phase 2 meeting is a crucial milestone for our refractory gout program" says Dr. Bing Li, Shanton's CEO, "as it provides alignment with FDA on our upcoming Phase 3 pivotal program, 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 program in the coming months, aiming to offer a much-needed solution for uncontrolled gout patients."

"This End-of-Phase 2 meeting is a crucial milestone for our refractory gout program" says Dr. Bing Li, Shanton's CEO, "as it provides alignment with FDA on our upcoming Phase 3 pivotal program, 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 program in the coming months, aiming to offer a much-needed solution for uncontrolled gout patients."

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 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.

Earlier this 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 upon currently available Urate Lowering Therapy for patients with refractory gout, a serious condition for which there are considerable unmet medical needs.

About Shanton Pharma

Shanton Pharma is a privately held, clinical-stage biotech founded in 2016 by experienced pharma entrepreneurs, focused on addressing unmet medical needs in patients with hyperuricemia and gout. The company is headquartered in Singapore with research and development activities in the US, China, and Singapore.

To learn more about Shanton Pharma, go to https://shantonpharma.com.

Media Contact

Pieter de Ridder
VP of Business Development
[email protected] 

Logo - https://mma.prnewswire.com/media/2473403/shanton_hi_res_logo_high_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/shanton-pharma-completes-eop2-meeting-with-us-fda-for-refractory-gout-program-302594532.html