SAP-001 is Shanton's lead investigational
compound with Best-in-Class potential in uncontrolled gout
PRINCETON,
N.J., Aug. 5, 2024 /PRNewswire/ -- Shanton
Pharma, a clinical-stage biotech company developing a
groundbreaking treatment for refractory and tophaceous gout
patients, today announced full enrollment of a Phase 2b study for its investigational drug
SAP-001.
"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.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 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. 2,3,4
About Shanton's Phase 2b Gout Study
Shanton's Phase 2b
study is a six-month, multi-center, 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.
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.
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.
SAP-001 is Shanton's lead investigational
compound for once-a-day oral urate-lowering therapy that targets
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 and safety in Phase 1 and Phase 2a clinical
studies in gout patients with hyperuricemia. Based on its clinical
profile and mechanism, SAP-001 has the potential to become the
Best-in-Class treatment for refractory and tophaceous gout.
To learn more about Shanton Pharma, go to
https://shantonpharma.com.
References
- 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.
- 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.
- Clarivate Incidence and Prevalence Data Base.
- Kasper, I.R., Juriga, M.D., Giurini, J.M., Shmerling, R.H.,
Treatment of tophaceous gout: When medication is not enough,
Seminars in Arthritis and Rheumatism, Volume 45, Issue 6, 2016,
669-674.
Media Contact
Pieter de
Ridder
VP of Business Development
pieter.ridder@shantonpharma.com
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SOURCE Shanton Pharma