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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