Shanton Pharma reaches full enrollment in phase 2b refractory/tophaceous gout study with SAP-001
Overview
Shanton Pharma, a clinical-stage biotech company developing a groundbreaking treatment for refractory and tophaceous gout patients, announced full enrollment of a phase 2b study for its investigational drug SAP-001.
Words from the CEO: Shanton
- Reaching full enrollment is an important milestone in our 6-month gout study” Shanton’s CEO Dr. Bing Li said, “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 1 and 2a 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 enroll 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 enrollment of the phase 2b study.
About Gout
- Gout is the most common form of inflammatory arthritis, and the second most prevalent metabolic disease caused by too much uric acid in the bloodstream, with over 10 million adult patients diagnosed in the US alone.
- Hyperuricemia, elevated serum uric acid levels, can over time result in gout when urate crystals are deposited in joints (tophi) and other body tissues, causing inflammatory responses and painful gout attacks (flares).
- Recurrent gout flares are debilitating and can lead to joint destruction and joint disfigurement.
Gout Treatment in US
- 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, and that up to a third of gout patients develop tophi.
Phase 2b Study
- Shanton’s phase 2b study is a six-month, multi-centre, 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 has now reached full enrollment with 87 patients from 21 US sites.
Primary Objective
- 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.
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 the US with research and development activities in the US, China, and Singapore.
