Shanton Completes Phase 2b Study Enrollment for SAP-001 in Refractory/Tophaceous Gout

Shanton Pharma, a company in the clinical-stage biotech sector, has announced the completion of participant enrollment for its Phase 2b study investigating SAP-001, a potential breakthrough treatment for refractory and tophaceous gout. This marks a significant milestone in the company's ongoing research efforts aimed at addressing the needs of patients who do not respond to conventional therapies.

Dr. Bing Li, CEO of Shanton Pharma, emphasized the importance of this achievement, highlighting that the completion of enrollment triggers the countdown to the release of topline data, expected in the first quarter of 2025. The main objective of this study is to assess the efficacy and safety of SAP-001 in a particularly challenging patient group—those who suffer from a severe form of gout and have limited treatment alternatives due to their refractory nature to conventional Xanthine Oxidase Inhibitors (XOIs) like allopurinol or febuxostat. 

Gout, the most common type of inflammatory arthritis, is caused by an excess of uric acid in the bloodstream. In the United States alone, over 10 million adults are diagnosed with this condition. Elevated levels of serum uric acid can lead to the formation of urate crystals in joints and tissues, triggering painful gout flares and potentially resulting in joint damage and disfigurement over time. Despite the availability of urate-lowering therapies (ULTs), a significant portion of gout patients do not adequately respond to current treatments. Statistics indicate that up to 20% of patients on standard treatments like allopurinol or febuxostat are physiologically refractory, and about one-third of gout patients develop tophi, hardened deposits of uric acid crystals.

Shanton’s Phase 2b study is particularly rigorous, focusing on patients who have not responded to the highest tolerable doses of traditional XOIs. This six-month clinical trial is multi-center, randomized, double-blind, placebo-controlled, and dose-ranging. It involves 87 participants across 21 sites in the United States. The primary goal is to evaluate SAP-001's effectiveness in reducing serum urate levels. Secondary objectives include assessing the drug's safety and tolerability, monitoring the frequency of gout flares, and measuring changes in the number, size, and mass of tophi.

Shanton Pharma, founded in 2016, focuses on addressing unmet medical needs related to hyperuricemia and gout. With headquarters in the US and research operations in the US, China, and Singapore, the company is led by seasoned pharmaceutical entrepreneurs. SAP-001 is their leading investigational compound, designed for once-daily oral administration to lower urate levels. Its unique mechanism-of-action has demonstrated exceptional efficacy and safety in earlier Phase 1 and Phase 2a studies. Given its promising clinical profile, SAP-001 has the potential to become the best-in-class treatment for both refractory and tophaceous gout.

In summary, the completion of enrollment in the Phase 2b study for SAP-001 is a pivotal step forward for Shanton Pharma in its mission to develop effective treatments for gout patients who have exhausted conventional options. The forthcoming topline data in early 2025 is eagerly anticipated and could represent a significant advancement in the management of this debilitating condition.

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