Shanton Reveals Topline Data from Phase 2b Study in Refractory Gout Patients

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SAP-001 is Shanton's lead investigational compound with First- and Best-in-Class potential in uncontrolled gout

SINGAPORE and PRINCETON, N.J., March 27, 2025 /PRNewswire/ -- Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout, today announced topline data of a Phase 2b study in refractory gout patients with its investigational drug SAP-001 that uses a First-in-Class Mechanism of Action targeting a distinct kidney transporter.

"We are excited and very pleased with the outcome of our Phase 2b clinical study in this difficult-to-treat population of refractory gout patients" says Dr. Bing Li, Shanton's CEO. "By the end of month 3 in our study, nearly 100% of patients that were confirmed exposed to daily SAP-001 30 and 60 mg dosages on top of conventional therapy reached the study's therapeutical target (serum uric acid levels below 6mg/dL), compared to only about 10% of patients on conventional treatment who reached that goal. The majority of treatment effects persisted until the end of treatment at month 6 of the study. More than half of those patients confirmed exposed to a daily 60 mg dose reached serum uric acid levels below 3mg/dL. Importantly, the study demonstrated an excellent safety profile in this population."

Shanton's gout program already showed excellent, best-in-class efficacy compared to other Urate Lowering Therapies in prior Phase 1 and 2a studies in regular gout patients, an outcome that has now been repeated in the challenging target population of refractory patients that often have a more severe form of gout with limited treatment options. Dr. Wenfeng Miao, Shanton's CMO adds: "This is the first successful clinical study with an oral gout drug to treat these refractory patients that normally need to be treated with an intravenous uricase. The efficacy of SAP-001 in this population is very impressive in all dosage groups at all assessed time points across the six months of treatment. We believe that the excellent efficacy and safety outcomes in this study show the exciting potential of our First-in-Class compound with its novel mechanism of action (MOA) that selectively targets a distinct kidney transporter for urate lowering treatment. The medical community has long been looking for this new mechanism in gout to address the shortcomings with conventional MOAs, especially where it comes to treating refractory and tophaceous patients. Our goal is to proceed into pivotal studies with our program later this year to eventually offer a paradigm-shifting gout treatment to our patients and make a big impact in their lives."

About Gout

Gout is the most common form of inflammatory arthritis and the second most prevalent metabolic disease. It is caused by too much uric acid in the bloodstream, with over 12 million adult patients diagnosed in the US alone.¹ Hyperuricemia, elevated serum uric acid levels, can over time result in gout when urate crystals are deposited in joints and other body tissues, causing inflammatory responses and painful gout attacks (flares). Recurrent gout flares are debilitating, and chronic gouty arthritis can over time lead to joint destruction and joint disfigurement.

About 29% of diagnosed gout patients in the US are treated with urate lowering therapies (ULTs), but only half of those patients sufficiently respond to or can tolerate current treatment options. It is estimated that up to 20% of US gout patients on standard-of-care allopurinol or febuxostat are physiologically refractory to these treatments. ^2,3

About Shanton's Phase 2b Gout Study

Shanton's Phase 2b study is a six-month, multi-center, randomized, double-blind, placebo-controlled, dose-ranging clinical study in refractory gout patients with or without tophi, to evaluate the efficacy and safety of a 10, 30, or 60 mg tablet dose of SAP-001. The study enrolled 87 patients from 21 US sites.

The Primary objective is to assess the effectiveness of SAP-001 in lowering serum urate levels in gout patients that are refractory to standard-of-care Xanthine Oxidase Inhibitor (XOI) therapy. Secondary study objectives include safety and tolerability assessments and frequency of gout flares among others.

About Shanton Pharma

Shanton Pharma is a privately held, clinical-stage biotech founded in 2016 by experienced pharma entrepreneurs, with a research focus on unmet needs associated with hyperuricemia and gout. The company is headquartered in Singapore with research and development activities in the US, China, and Singapore.

SAP-001 is Shanton's lead investigational compound for once-a-day oral urate-lowering therapy that targets refractory gout. SAP-001's urate lowering properties are based on a unique mechanism-of-action and the product has shown unparalleled efficacy and safety in Phase 1 and Phase 2a clinical studies in gout patients with hyperuricemia, and now also has shown Best-in-Class efficacy and safety in gout patients with hyperuricemia refractory to Standard of Care Xanthine Oxidase Inhibitor therapy.

To learn more about Shanton Pharma, go to https://shantonpharma.com.

References

1. Yokose C, McCormick N, Lu N, et al. Trends in Prevalence of Gout Among US Asian Adults, 2011-2018. JAMA Netw Open. 2023.
2. Juraschek SP, Kovell LC, Miller ER 3rd, Gelber AC. Gout, urate-lowering therapy, and uric acid levels among adults in the United States. Arthritis Care Res (Hoboken). 2015.
3. Clarivate Incidence and Prevalence Data Base

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SOURCE Shanton Pharma