Time: 2024-08-07
Shanton Pharma , a clinical - stage biotech company , has successfully enrolled patients in a Phase 2b study for SAP-001 , a potential treatment for refractory and tophaceous gout . The study , which is set to complete in 6 months , aims to evaluate the efficacy and safety of SAP-001 in patients who do not respond to standard treatments like allopurinol or febuxostat . The CEO of Shanton Pharma , Dr. Bing Li , highlighted the importance of reaching full enrollment as it paves the way for top - line data readout in Q1 2025.
Gout , an inflammatory arthritis condition caused by elevated uric acid levels , affects over 10 million adults in the US . Patients with hyperuricemia can develop gout when urate crystals accumulate in joints , leading to debilitating flares and potential joint damage . Current treatments , such as Xanthine Oxidase Inhibitors , may not be effective for all patients , with up to 20 % of individuals being refractory to these medications and up to a third developing tophi.
The Phase 2b study conducted by Shanton Pharma is a multi - center trial involving 87 patients across 21 sites in the US . The primary objective of the study is to assess the effectiveness of SAP-001 in lowering serum urate levels in refractory gout patients . Secondary objectives include evaluating safety , frequency of gout flares , and changes in tophi characteristics . SAP-001 , the lead investigational compound of Shanton Pharma , offers a unique mechanism of action for once - a - day oral urate - lowering therapy , showing promising results in earlier clinical trials.
Founded in 2016 , Shanton Pharma is dedicated to addressing unmet medical needs related to hyperuricemia and gout . The company 's research activities span across the US , China , and Singapore , with a focus on developing innovative treatments for refractory and tophaceous gout . SAP-001 has the potential to become a best - in - class therapy for patients with challenging forms of gout , providing hope for those who do not respond well to conventional Xanthine Oxidase Inhibitors like allopurinol.
In conclusion , Shanton Pharma 's Phase 2b study marks a significant milestone in the development of SAP-001 as a promising treatment option for refractory and tophaceous gout patients . With full enrollment achieved , the company is on track to deliver valuable insights into the efficacy and safety of this innovative drug , potentially revolutionizing the management of this debilitating condition.