Pediatric clinical studies of SAP-001 in hyperuricemia and gout are not needed
Significant clinical trial burden and costs avoided due to waiver
, /PRNewswire/ — Shanton Pharma, a clinical-stage biotech developing a novel treatment for hyperuricemia and gout in adults, today announced that it has reached 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 pediatric age subsets with hyperuricemia of any cause other than chronic kidney disease or obesity. This waiver follows that of the Agreed initial Pediatric Study Plan filed with the US Food and Drug Administration (“FDA”) in May of this year which exempts SAP-001 from pediatric study requirements due to the extremely low prevalence of gout in children.
“We are pleased that the EMA and FDA have determined that pediatric clinical studies evaluating SAP-001 are not needed to support market authorization applications for hyperuricemia and gout,” stated Bing Li, Ph.D., Chief Executive Officer. “The EMA and FDA waivers significantly lessen the administrative and regulatory burden and lower the overall cost of clinical development of SAP-001.”
“The regulatory waivers granted by EMA and FDA allow Shanton to streamline its development of SAP-001. It is another step forward towards introduction of this potent First-in-Class oral urate-lowering therapy, that addresses unmet needs in gout not adequately controlled by approved oral urate-lowering medications,” stated Robert Terkeltaub, M.D., Professor Emeritus of Medicine, UCSD. “SAP-001 has the potential to be a new entry point in the treatment paradigm for uncontrolled/refractory gout.”
About SAP-001
SAP-001 is Shanton’s lead investigational compound for once-a-day oral urate-lowering therapy that targets uncontrolled/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.
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 upon currently available Urate Lowering Therapy for patients with uncontrolled/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.
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