Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

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


News provided by

Shanton Pharma

09 Jan, 2023, 14:00 GMT

Share this article

Share toX

Share this article

Share toX

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, N.J., Jan. 9, 2023 /PRNewswire/ -- 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 

Modal title

Also from this source

Shanton to Present Topline Data from Phase 2b Study with SAP-001 in Refractory Gout Patients at EULAR 2025 Congress

Shanton to Present Topline Data from Phase 2b Study with SAP-001 in Refractory Gout Patients at EULAR 2025 Congress

Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout, today announced that it will be presenting topline data of...

Shanton Reveals Topline Data from Phase 2b Study in Refractory Gout Patients

Shanton Reveals Topline Data from Phase 2b Study in Refractory Gout Patients

Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout, today announced topline data of a Phase 2b study in...

More Releases From This Source

Explore

Biotechnology

Biotechnology

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Clinical Trials & Medical Discoveries

Clinical Trials & Medical Discoveries

News Releases in Similar Topics

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.