Shanton Screens First Subjects in Phase 2b Refractory/Tophase Gut Study with SAP-001
SAP-001 is an investigational once-daily oral gout product with Finest-in-Class potential for acute and persistent use in uncontrolled sufferers.
BRIDGEWATER, NJ, January 9, 2023 /PRNewswire/ — Shanton Pharma, a clinical-stage biotechnology firm creating a breakthrough therapy for sufferers with resistant and tophi gout, immediately introduced the beginning of a Section one RID GOUT Trial 2b Research for Shanton’s investigational drug SAP-001.
“Gout is a persistent storage illness with extreme comorbidities related to the buildup of uric acid within the joints and different tissues and organs. There’s a clearly unmet medical want right here as sufferers have little option to deal with their (persistent) refractory and tophus gout.” stated Dr. Zhenhua Huang, President of Shanton Pharma. “Shanton, with its extremely skilled workforce, is nicely positioned to offer an optimized resolution to this underserved affected person inhabitants for each tophus dissolution and serum uric acid normalization, primarily based on the promising security and efficacy profile of SAP-001.”
Gout is the most typical type of inflammatory arthritis and the second most typical metabolic illness attributable to an excessive amount of uric acid within the bloodstream, with 10 million sufferers recognized within the US alone.one Hyperuricemia, excessive serum uric acid ranges, urate crystals can accumulate within the joints (tophus) and different physique tissues, inflicting inflammatory responses and painful gout assaults (flares) over time, resulting in gout. Recurrent gout flares are debilitating and may result in joint destruction and joint disfigurement.
About one-third of sufferers recognized within the US are handled with urate-lowering therapies (ULTs), however solely half of those sufferers adequately reply to or tolerate out there therapy choices. This leaves a couple of million US sufferers and greater than 8 million worldwide with out therapy choices. 2.3
About RID GOUT Operation
RID GOUT, Shanton’s Stage 2b examine, 10, 30, or 60 mg pill dose SAP-001 in sufferers with (persistent) refractory gout with or with out tophi. The corporate goals to recruit a complete of 80 sufferers from roughly 25 US services. Greater than 10 facilities have already been initiated, sufferers have been recognized for inclusion, consent and screening.
The first purpose was to guage the efficacy of SAP-001 in decreasing serum urate ranges in sufferers with gout refractory to straightforward of care xanthine oxidase inhibitor (XOI) remedy. Secondary examine targets embrace assessments of security and tolerability, frequency of gout flares, and variation in tophus quantity, measurement, and mass.
Dr. Bing Li, CEO of Shanton Pharma. “We hope to exhibit that SAP-001 can considerably scale back elevated serum uric acid ranges to ranges that ought to lead to decision of painful tophi in refractory hyperuricemic sufferers.”
About Shanton Prescribed drugs
Shanton Pharma is a personal clinical-stage biotechnology firm based in 2016 by extremely skilled pharmaceutical entrepreneurs specializing in the unmet wants related to hyperuricemia and gout. The corporate is headquartered within the USA and its analysis and growth actions are within the USA, Chinese languageand Singapore.
Shanton’s lead program SAP-001 is a once-daily investigative oral monotherapy concentrating on (persistent) refractory and tophasous gout. The urate-lowering properties of SAP-001 are primarily based on a novel mechanism of motion and the product has demonstrated unparalleled efficacy, response charges, and security in Section 1 and Section 2a medical trials in sufferers with gouty hyperuricemia. SAP-001 is a handy oral remedy supplied in a wide range of pill strengths designed to offer versatile dosing: decreasing upkeep remedy at the next dose as an acute remedy and a decrease pill power as a persistent urate to enhance tophus dissolution by considerably decreasing serum uric acid ranges. Based mostly on its medical profile, SAP-001 has the potential to be a Finest-in-Class remedy for (persistent) refractory and/or tophasous gout.
To be taught extra about Shanton Pharma, go to: https://shantonpharma.com.
- Chen-Xu, M., Yokose, C., Rai, SK, Pillinger, MH, and Choi, HK (2019), Up to date Prevalence of Gout and Hyperuricemia in United States and Decadal Developments: Nationwide Well being and Vitamin Examination Survey, 2007–2016. Arthritis Rheumatol, 71: 991-999.
- Juraschek SP, Kovell LC, Miller ER third, Gelber AC. Grownup gout, urate-lowering remedy and uric acid ranges United States. Arthritis Care Res (Hoboken). 2015 Apr;67(4):588-92. doi: 10.1002/acr.22469. PMID: 25201123; PMCID: PMC4362996.
- Richette P, Clerson P, Périssin L, Flipo RM, Bardin T. Revisiting gutta comorbidities: a cluster evaluation. Ann Rheum Dis. 2015 Jan;74(1):142-7. doi: 10.1136/annrheumdis-2013-203779. Epub 2013 October 9. PMID: 24107981.
Peter de Ridder
Vice President of Enterprise Improvement
SOURCE Shanton Prescribed drugs
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