Shanton Pharma, a clinical-stage biotech company focused on novel therapies for gout, has announced that the U.S. FDA has granted Fast Track designation to its lead investigational drug SAP-001. The designation applies to the treatment of hyperuricemia in adult patients with gout who are unresponsive to conventional therapies.
A Step Forward for Patients with Limited Options
“We are excited about the Fast Track designation for SAP-001.Refractory gout is a debilitating condition with considerable unmet medical needs. This designation allows us to engage more closely with FDA and accelerate the development timeline for a much-needed treatment option for patients who don’t respond to, or can’t tolerate, current standard urate-lowering therapies.”
said Dr. Wenfeng Miao, Chief Medical Officer at Shanton Pharma.
Backed by Promising Phase 2b Results
The FDA’s decision follows encouraging safety and efficacy data from a Phase 2b clinical study, where SAP-001 demonstrated meaningful improvements over currently available urate-lowering therapies in patients with refractory gout.
The study showed that SAP-001 may offer both improved tolerability and better clinical outcomes in this difficult-to-treat population.
What Fast Track Designation Means?
The Fast Track program is designed to expedite the development and review of drugs for serious or life-threatening conditions with unmet medical needs. Benefits of this designation include:
- More frequent interactions with the FDA
- Early and continuous feedback during development
- Rolling submission of NDA sections
- Potential eligibility for priority review and accelerated approval
About SAP-001
SAP-001 is Shanton Pharma’s lead investigational therapy, developed as a once-daily oral treatment for refractory gout. It operates via a First-in-Class mechanism of action and has demonstrated Best-in-Class efficacy and safety in patients who are not responsive to Xanthine Oxidase Inhibitors, the current standard of care.
About Shanton Pharma
Founded in 2016, Shanton Pharma is a privately held biotech company based in Singapore, with R&D operations in the U.S., China, and Singapore.
The company specializes in drug development for hyperuricemia and gout, targeting areas of high unmet clinical need. Its mission is to bring innovative, science-driven solutions to patients worldwide.
