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Shanton Screens First Subjects in Phase 2b Refractory/Tophaceous Gout Study with SAP-001

Jan 09, 2023 / Shanton

SAP-001 is an oral once-a-day investigational gout product with Best-in-Class potential for acute and chronic use in uncontrolled patients

 

BRIDGEWATER, NJ – 9 January 2023 – Shanton Pharma, a clinical-stage biotech company developing a groundbreaking treatment for refractory and tophaceous gout patients, today announced the initiation of its RID GOUT Study, a Phase 2b study for Shanton’s investigational drug SAP-001.

“Gout is a chronic storage disease with serious comorbidities associated with accumulation of uric acid in joints and other tissues and organs. There is a clear unmet medical need here as patients have very few options to treat their (chronic) refractory and tophaceous gout” said Dr. Zhenhua Huang, Chairman of Shanton Pharma. “Shanton, with its highly experienced team, is well positioned to provide an optimized solution to this underserved patient population for both tophi dissolution and serum uric acid normalization, based on the promising safety and efficacy profile of SAP-001.”


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 10 million 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 (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.

About a third of diagnosed 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. This leaves more than a million US patients and over 8 million patients worldwide without treatment options. 2,3


About the RID GOUT Study

RID GOUT, Shanton’s Phase 2b study, is a six-month, multi-center, randomized, double-blind, placebo-controlled, dose-ranging clinical study in (chronic) 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 company targets to recruit a total of 80 patients from approximately 25 US sites. More than 10 sites have already been initiated, with patients identified for enrollment into the trial, consented and in screening.

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, frequency of gout flares, and change in tophi number, size, and mass.

“Over 1 million US gout patients are uncontrolled with current medication. The RID GOUT study aims to further confirm the potency and the safety profile of SAP-001 that were observed in the prior Phase 2a study in hyperuricemia patients with gout,” said Dr. Bing Li, CEO of Shanton Pharma. “We expect to show that SAP-001 is able to significantly reduce high serum uric acid levels to those that should result in dissolution of painful tophi in refractory hyperuricemic patients.”


About Shanton Pharma

Shanton Pharma is a privately held, clinical-stage biotech founded in 2016 by highly 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.

Shanton’s lead program SAP-001 is an investigational once-a-day oral monotherapy that targets (chronic) refractory and tophaceous gout. SAP-001’s urate lowering properties are based on a unique mechanism-of-action and the product has shown unparalleled efficacy, response rates, and safety in Phase 1 and Phase 2a clinical studies in hyperuricemia patients with gout. SAP-001 is a convenient oral treatment that comes in various tablet strengths designed to enable flexible dosing: at a higher dose as an acute therapy to enhance tophi dissolution by significantly lowering serum uric acid levels, and at a lower tablet strength as a chronic urate lowering maintenance therapy. Based on its clinical profile, SAP-001 has the potential to become the Best-in-Class treatment for (chronic) refractory and/or tophaceous gout.

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


References

1. Chen-Xu, M., Yokose, C., Rai, S.K., Pillinger, M.H. and Choi, H.K. (2019), Contemporary Prevalence of Gout and Hyperuricemia in the United States and Decadal Trends: The National Health and Nutrition Examination Survey, 2007–2016. Arthritis Rheumatol, 71: 991-999.

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 Apr;67(4):588-92. doi: 10.1002/acr.22469. PMID: 25201123; PMCID: PMC4362996.

3. Richette P, Clerson P, Périssin L, Flipo RM, Bardin T. Revisiting comorbidities in gout: a cluster analysis. Ann Rheum Dis. 2015 Jan;74(1):142-7. doi: 10.1136/annrheumdis-2013-203779. Epub 2013 Oct 9. PMID: 24107981.


Media Contact

Pieter de Ridder
VP of Business Development
pieter.ridder@shantonpharma.com
Source: Shanton Pharma USA, Inc.