Companies enter into an exclusive, multi-year partnership to employ non-invasive, lipidomics-based diagnostic testing to establish a database enriched for subjects with NAFLD/NASH
SAN DIEGO and DERIO, SPAIN, June 7, 2017 /PRNewswire/ – ProSciento, Inc., a full scope clinical R&D services provider focused exclusively on metabolic diseases, and OWL Metabolomics, a biotechnology company pioneering virtual biopsy assays for the diagnosis of NAFLD/NASH, announced today an exclusive, multi-year collaboration aimed at identifying individuals who are eligible for enrollment into clinical trials of therapeutic candidates to treat NAFLD (non-alcoholic fatty liver disease) and NASH (steatohepatitis). Under the terms of the agreement, the companies will collaborate to establish a database of prospective clinical study participants evaluated for the presence of NAFLD and NASH using OWL’s non-invasive, lipidomics-based diagnostic assays. The initiative, aimed at accelerating enrollment and reducing screen failure rates in NAFLD/NASH clinical trials, will be launched at ProSciento’s early phase clinical research unit and subsequently expanded within ProSciento’s network of metabolism-focused study sites. In conjunction with this agreement, OWL will join ProSciento’s CRI (Clinical Research Innovation) partner network, a select group of corporate and academic collaborators offering novel clinical research methodologies to support and accelerate metabolic drug and device development.
“In recent years, advances in basic, clinical and regulatory science have led to a growing biopharmaceutical pipeline of NAFLD/NASH drug candidates, yet progress in translational research has been hindered in part by challenges in clinical trial recruitment,” said Christian Weyer, M.D., ProSciento’s President and Chief Development Officer. “OWL’s lipidomics-based assays, developed and validated in sizable cohorts of biopsy-proven NAFLD/NASH patients, hold great promise as a non-invasive method of identifying potential clinical research subjects and reducing screen failure rates. We are very pleased to partner with the team at OWL to apply innovative, science-driven solutions to one of the major unmet needs in this exciting new field of metabolic drug development.”
ProSciento has a proprietary site database of more than 30,000 active study participants enriched for diabetes, obesity, and related metabolic conditions. In addition, as part of its full scope CRO services providing oversight of metabolism-focused multi-center studies, ProSciento has access to more than 900,000 study participants through its current network of study sites. Building upon this foundation, the partnership with OWL seeks to further improve the identification of individuals who are eligible for enrollment into NAFLD/NASH clinical trials, using non-invasive blood tests.
“We are excited to join forces with ProSciento, a global leader in metabolism-focused clinical R&D that shares our deep commitment to scientific innovation in NAFLD/NASH drug development and patient care,” said Pablo Ortiz, M.D., Ph.D., OWL’s Chief Executive Officer. “Non-invasive biomarkers are rapidly emerging as crucial enabling tools in this field, and our novel OWLiver Care® and OWLiver® tests for the characterization of potential clinical study participants is but one example of how our patented lipidomics-based assays can be applied to aid the clinical development of NAFLD/NASH drug candidates using safe, simple and clinically-proven testing technology.”
NAFLD/NASH represents a rapidly growing and evolving field of biopharmaceutical R&D, with a sizable number of drug candidates advancing through the various stages of preclinical and clinical development. While liver biopsy is currently considered a ‘gold standard’ method for diagnosing NAFLD/NASH and assessing treatment responses, it is widely recognized that there is a significant need for validated, non-invasive biomarkers to support and improve drug development and clinical care.
About OWL Metabolomics
OWL Metabolomics is a biotechnology company committed to the identification, validation and global commercialization of novel diagnostic assays for the liver and other prevalent human diseases, including the identification of potential therapeutic targets involved in the development of such diseases. Since its inception in 2002, OWL has pioneered unique diagnostic research within the fatty liver space, a field of considerable focus in new drug development.
The ‘OWLiver’ and ‘OWLiver Care’ assays are the world’s first metabolomics-based in-vitro tests for diagnosing non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD), respectively, using micro-blood samples (<0.3 ml) versus today’s diagnostic gold-standard which mandates an invasive liver biopsy. For more information on OWL technology, visit http://www.owlmetabolomics.com/liver-disease-diagnosis.aspx
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About ProSciento, Inc.
ProSciento is a metabolism-focused, full scope clinical R&D services provider, with a mission to advance the global development of novel therapeutics for diabetes, NASH and obesity. The company is widely recognized for quality and scientific excellence, an unparalleled methodological toolkit, and extensive experience with virtually all metabolic drug and device classes. Utilizing its scalable R&D services model – combining deep therapeutic area expertise, strategic planning, an unparalleled methodological tool kit, and operational execution from late preclinical to phase III readiness – ProSciento provides highly customizable services for its global client base in today’s rapidly evolving landscape of metabolic drug and device development. For more information, please visit www.prosciento.com.
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