ProSciento, 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 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 multicenter 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."