Shanton Unveils Phase 2b Study Results for Refractory Gout Patients

Shanton Pharma, a clinical-stage biotech company, has taken a significant stride in the treatment of refractory gout with its investigational drug SAP-001. The company recently announced the promising results of a Phase 2b clinical study, which targets gout resistant to standard therapies. The study involves a novel oral medication, SAP-001, which works with a unique mechanism that targets a specific kidney transporter to reduce uric acid levels.

Dr. Bing Li, CEO of Shanton Pharma, expressed his excitement over the study's positive results. "We are thrilled with the outcomes in this challenging group of refractory gout patients," he stated. By the three-month mark, almost all patients receiving daily doses of SAP-001 at 30 and 60 mg, alongside conventional treatments, achieved the therapeutic goal of lowering serum uric acid levels below 6 mg/dL. This was a remarkable contrast to the mere 10% of patients on standard therapies who reached the same target. Moreover, many patients continued to experience beneficial effects even after six months of treatment. More than half of the patients on the 60 mg daily dosage managed to lower their serum uric acid levels below 3 mg/dL. The safety profile of SAP-001 was also deemed excellent.

The study underscores Shanton Pharma's continued success in developing effective treatments for gout. Previous Phase 1 and Phase 2a studies demonstrated SAP-001’s superior efficacy compared to other uric acid-lowering therapies in regular gout patients. The Phase 2b study further confirms its effectiveness in patients with refractory gout, a condition characterized by severe symptoms and limited treatment options. Dr. Wenfeng Miao, Chief Medical Officer of Shanton, highlighted the significance of the study, saying, "This marks the first successful clinical trial of an oral drug for refractory gout patients, who typically require intravenous uricase treatment." He praised the drug's impressive efficacy across different dosage groups and time points throughout the six-month treatment period.

The promising results of SAP-001 in refractory gout patients herald an exciting development in gout treatment, particularly due to its unique mode of action targeting a specific kidney transporter. The medical community has long sought such advancements to address the limitations of conventional therapies, especially for patients with severe symptoms or those who are resistant to existing treatments. Shanton Pharma aims to advance this program to pivotal studies later in the year, with the ultimate goal of introducing a transformative gout treatment that significantly improves patients' lives.

Gout is the most prevalent form of inflammatory arthritis, affecting over 12 million adults in the United States alone. It results from excessive uric acid in the bloodstream, leading to the formation of urate crystals in the joints and other tissues, causing painful gout attacks. While urate-lowering therapies are available for treatment, approximately 20% of gout patients in the US are refractory to standard medications like allopurinol or febuxostat.

Shanton Pharma's Phase 2b study is a rigorous, multi-center, randomized, double-blind, placebo-controlled trial spanning six months. It aims to evaluate the efficacy and safety of SAP-001 in doses of 10, 30, or 60 mg, specifically in patients with refractory gout, with or without tophi. Conducted at 21 sites across the US, the study enrolled a total of 87 participants. The primary focus is on assessing the drug's ability to lower serum urate levels in patients unresponsive to standard Xanthine Oxidase Inhibitor therapy, with secondary objectives including safety and tolerability assessments, as well as monitoring the frequency of gout flares.

Founded in 2016, Shanton Pharma is a privately held biotech company dedicated to addressing unmet medical needs related to hyperuricemia and gout. With its headquarters in Singapore and research activities in the US, China, and Singapore, Shanton is committed to advancing innovative treatments for gout. SAP-001, the company's leading investigational compound, boasts unparalleled efficacy and safety in treating gout patients, including those unresponsive to standard therapies.