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 growing a breakthrough therapy for sufferers with resistant and tophi gout, immediately introduced the beginning of a Part 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.” mentioned Dr. Zhenhua Huang, President of Shanton Pharma. “Shanton, with its extremely skilled crew, is nicely positioned to offer an optimized answer 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 brought on by 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 might 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 multiple 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 research, 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 intention was to judge 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 research aims embody assessments of security and tolerability, frequency of gout flares, and variation in tophus quantity, dimension, and mass.
Dr. Bing Li, CEO of Shanton Pharma. “We hope to show that SAP-001 can considerably scale back elevated serum uric acid ranges to ranges that ought to end in decision of painful tophi in refractory hyperuricemic sufferers.”
About Shanton Prescription 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 singular mechanism of motion and the product has demonstrated unparalleled efficacy, response charges, and security in Part 1 and Part 2a scientific trials in sufferers with gouty hyperuricemia. SAP-001 is a handy oral remedy provided in a wide range of pill strengths designed to offer versatile dosing: reducing upkeep remedy at a better dose as an acute remedy and a decrease pill energy as a persistent urate to enhance tophus dissolution by considerably reducing serum uric acid ranges. Primarily based on its scientific profile, SAP-001 has the potential to be a Finest-in-Class remedy for (persistent) refractory and/or tophasous gout.
To study 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 Traits: Nationwide Well being and Diet 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 Growth
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