SAN DIEGO, Feb. 6, 2020 /PRNewswire/ –ProSciento, Inc., a clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity and related metabolic diseases, announced today a strategic partnership with Nordic Bioscience, a precision drug development and biomarker technology company. The partnership will utilize ProSciento’s NASH PASS™ patient registry and Nordic Bioscience’s biomarker technology to identify and validate translational biomarkers to improve the diagnosis, prognosis and development of therapeutics for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).
Clinical Need for Validated Diagnostic Biomarkers
Currently, liver biopsy continues to be the primary method to diagnosis and monitor NAFLD and NASH. However, liver biopsies are costly, carry a risk of complications for the patient, and are not always representative of the health status of the entire liver. Identifying and validating noninvasive (or minimally invasive) biomarkers is an urgent, unmet clinical need and will support critically needed advancements in the diagnosis and development of treatments for patients with NAFLD and NASH.
Moreover, because of current uncertainties surrounding the effectiveness of diagnostic tests and the lack of FDA-approved therapeutic options, medical practice guidance from the American Association for the Study of Liver Diseases does not advise routine screening, even for high‐risk patient populations.* These challenges associated with screening patients for NASH led ProSciento to develop the NASH PASS™ predictive screening methodology and clinical protocol to provide medical care providers an opportunity to offer screenings for their at-risk patients with consent that this diagnostic data is used to enhance scientific knowledge of NAFLD and NASH disease progression and the utility of diagnostic and prognostic biomarkers.
About ProSciento’s NASH PASS™
ProSciento’s NASH PASS™ is a science-driven clinical development platform designed to address enrollment challenges in NASH clinical trials; to enhance the understanding of natural disease progression; and to serve as a biomarker discovery and validation platform. NASH PASS™ integrates a proprietary screening methodology utilizing biomarkers, predictive algorithms, and a broad range of assessments; an IRB-approved clinical protocol; and a patient registry of current diagnostic data. The NASH PASS™ screening method is used to diagnose and differentiate between healthy, NAFLD and NASH with a single blood draw and to utilize imaging modalities or liver biopsy in a highly predictive manner. ProSciento works with select, prequalified clinical centers across the U.S. to establish opt-in routine screenings of patients at high risk for the development of the NASH, such as patients diagnosed as obese or with type 2 diabetes, within their primary care setting. The screening assessment data is used to determine patient eligibility for clinical research, as well as to identify individuals with NASH from a high‐risk population who will progress to imaging or biopsy procedures. To date, ProSciento’s NASH PASS™ registry includes more than 1,000 screened individuals.
About Nordic Bioscience’s Protein FingerPrint™ technology
Nordic Bioscience’s Protein FingerPrint™ technology has delivered a broad range of novel and proprietary protein biomarkers for applications in the diagnosis and prognosis of important diseases. Most of these biomarkers detect structural components of the extracellular matrix (ECM) and have been successfully validated in clinical studies of patients diagnosed with musculoskeletal disorders, fibrosis and cancer. The PRO-C3 biomarker detecting neoepitope fragments of Collagen Type III has demonstrated an association with poor prognosis in fibrotic liver diseases, such as NAFLD and NASH, and will be further evaluated through the partnership with ProSciento.
“We’re very pleased to be partnering with Nordic Bioscience to combine the scientific insight from our access to real-time, longitudinal patient data and biological samples and their cutting-edge biomarker discovery expertise. Bringing together our areas of expertise specific to NASH research provides a much-needed opportunity to gain a better understanding of disease progression and establish new diagnostic and prognostic biomarkers to support safe, effective drug development,” said Marcus Hompesch, MD, ProSciento’s Chief Executive Officer.
“ProSciento’s expertise conducting NASH clinical studies and patient access via its NASH PASS™ program, combined with the complementary expertise and technology at Nordic Bioscience, promises to make this a transformative collaboration for the advancement of NAFLD/NASH research,” said Morten Karsdal, PhD, Nordic Bioscience’s Chief Executive Officer.
About Nordic Bioscience A/S
Nordic Bioscience is a Danish biotech company with more than 25 years of experience in biomarker development and clinical trials for fibrosis, rheumatology and oncology, including a portfolio of more than 70 validated proprietary biomarkers. Nordic Bioscience liaises with pharmaceutical and biotech clients to identify projects most suitable for clinical development, utilizing its unique biomarker technology, and assists clients in understanding a compound’s mode of action and optimal dosing.
Combining experience in preclinical and clinical research enables Nordic Bioscience to help provide a faster and smarter detection of signals of the potential clinical viability of drug candidates. For more information, please visit www.nordicbioscience.com.
About ProSciento, Inc.
ProSciento is a specialized clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity and related metabolic diseases. ProSciento works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has conducted more than 300 clinical projects for NASH, diabetes and obesity and supported the development of many metabolic drugs and devices on the market globally. For more information, please visit www.prosciento.com.
*Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357.