Shanton Pharma has announced the full subject enrolment in its Phase IIb clinical trial of SAP-001, a potential new treatment for refractory and tophaceous gout.
The six-month, multi-centre, randomised, double-blind, placebo-controlled, dose-ranging trial enrolled 87 patients across 21 sites in the US.
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It aims to assess the efficacy and safety of three different doses of SAP-001.
The primary goal is to determine the asset’s effectiveness in reducing serum urate levels in patients who do not respond to standard xanthine oxidase inhibitor (XOI) therapy.
Secondary objectives include assessing safety and tolerability, the frequency of gout flares, and changes in the number, size, and mass of tophi.
SAP-001, the company’s lead investigational compound, is a once-daily oral urate-lowering therapy targeting refractory and tophaceous gout.
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By GlobalDataThe drug’s urate-lowering properties are based on a unique mechanism of action, and it has demonstrated significant efficacy and safety in earlier Phase I and Phase IIa clinical trials.
Given its clinical profile and mechanism, SAP-001 is positioned to potentially become the best-in-class treatment option for patients with refractory and tophaceous gout, addressing a significant gap in current treatment options.
Shanton Pharma CEO Dr Bing Li said: “Reaching full enrolment is an important milestone in our 6-month gout study as this sets the clock for topline data readout in Q1 2025.
“The study aims to show similar good efficacy and safety results that we saw in our Phase I and IIa studies in regular gout patients, but now in the more challenging target population of truly refractory patients that often have a more severe form of gout with limited treatment options.
“The challenge of this study was to just enrol patients that do not respond to a maximum tolerable dose of conventional Xanthine Oxidase Inhibitors such as allopurinol or febuxostat, which we have now accomplished through full enrolment of the Phase IIb study.”
Founded in 2016, Shanton focuses on addressing the unmet medical needs related to hyperuricemia and gout.
The company conducts research and development in the US, China, and Singapore.
