Categories
press-releases

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

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, NJ – 9 January 2023 – 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
Source: Shanton Pharma USA, Inc.

Categories
senior-management

Bing Li, Ph.D.

Dr. Li carries more than 25 years of experience in healthcare, and is highly regarded as a strong business leader with extensive experience in creating/turning around businesses in pharma and biotech industries.

Dr. Li’s previous positions include the founding CEO of LianBio (Nasdaq: LIAN), CEO of China Biologic Products (Nasdaq: CBPO), leader of Fosun global healthcare investment teams, leader of Warburg Pincus pharma/biotech practice in China, and management positions at GSK China and Eli Lilly.

Dr. Li received a Ph.D. in Biology from University of Rochester, an M.B.A. from Kellogg Management School and B.S. from Fudan University.

Categories
senior-management

Pieter de Ridder, MBA

Pieter de Ridder is an experienced business development executive with a track record in the international biopharma industry. He has worked for global pharma (Organon, Diosynth) as well as high-growth emerging biotech companies (Synthon) in roles of increasing responsibility. He has negotiated dozens of deals for biotechs with large and midsized pharma, planned impactful product launches, and managed successful alliances. As the founder of a management consultancy, he assisted life sciences startups by writing impactful business plans and negotiating their first deals.

Mr. De Ridder earned his bachelor’s degree from Avans Hogeschool in Breda, the Netherlands, and an executive MBA from Duke University – The Fuqua School of Business in Durham, NC.

Categories
senior-management

Koji Matsuyama, Ph.D.

Dr. Matsuyama is the Founder of Shanton Pharma and has been engaged in researching and developing innovative drugs in the pharmaceutical industry for more than 20 years.

Dr. Matsuyama received a Ph.D. in Biology from the University of Tokyo.

Categories
senior-management

Qian Zhang

Qian Zhang is the Project Manager of Shanton Pharma and has been engaged in preclinical and non-clinical coordination management, research and development of innovative drugs in the pharmaceutical industry for more than 14 years.

Categories
financials

Shanton Pharma

Categories
scientific-advisors

Andrew Whelton, MD

Dr. Andrew Whelton is Professor of Medicine (Adjunct), also ex-Director of the Division of Nephrology at The Johns Hopkins University School of Medicine. He has over 50 years of pharmaceutical experience and focuses on Clinical Drug Development and Safety. He is a Special Government Officer, Consultant to the Food and Drug Administration and Member, ad hoc, of the Arthritis Advisory Committee Food and Drug Administration, appointed by Federal Government since the 1990s.

Dr. Whelton is also an expert in the field of renal and cardiovascular disease. He has authored over one hundred and eighty scientific articles, book chapters and reviews on the topics of renal disease, cardiovascular, hyperuricemia and gout. He was also appointed as Chairman of Maryland Commission on Kidney Disease.

Categories
scientific-advisors

N.Lawrence Edwards,MD,MACP,MACR

Dr. N. Lawrence Edwards is Professor of Medicine, Division of Rheumatology and Clinical Immunology, as well as Program Director and Vice Chairman of the Department of Medicine at the University of Florida in Gainesville. He is the Chairman and CEO of the Gout Education Society, a non-profit, patient education organization, for the past 14 years (www.gouteducation.org). Dr. Edwards is an active member of many professional organizations including the American College of Rheumatology, American College of Physicians, the Association of Program Directors in Internal Medicine and is the Past-President of the National Society of Clinical Rheumatologists.

Dr. Edwards obtained his undergraduate training at the University of Notre Dame and his medical degree from the University of Miami School of Medicine. He has authored over one hundred and fifty scientific articles, book chapters and reviews on the topics of hyperuricemia, gout, and purine metabolism.

Categories
scientific-advisors

William B. White, MD

Dr. William White is Professor of Medicine and Chief of the Division of Hypertension and Clinical Pharmacology in the Calhoun Cardiology Center at the University of Connecticut School of Medicine where he has worked for 40 years. In addition, Dr. White is the founder and former Medical Director of the Clinical Trials Unit at the University of Connecticut Health Center in Farmington.

Dr. White graduated from Emory University with a Bachelor of Science Degree in Biology/Chemistry and obtained his medical degree from Medical College of Georgia. He is the author of over 475 articles and book chapters, mainly in the field of cardiovascular medicine and therapeutics.

Categories
scientific-advisors

Robert Segal, M.D., FACP

Dr. Robert Segal is Board Certified Internist/ Nephrologist with more than 20 years of broad experience in drug/device development, global clinical research, regulatory strategy/authority interaction, government funding and scientific affairs. He is thorough familiarity with aspects related to intellectual property and orphan drug/fast track applications. He has received Federal and Biodefense funding and contracts, including five NIH SBIR (Small Business Innovative Research) grants/contracts worth around $10 Million.
 
Dr. Segal holds an active MD license in Pennsylvania and previously got licensed in Maryland, California, the UK and South Africa.