ProSciento Inc, San Diego, and Owl Metabolomics, Derio, Spain, have signed an exclusive, multiyear collaboration aimed at identifying individuals who are eligible for enrollment in clinical trials of therapeutic candidates to treat non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Under the terms of the agreement, the companies will collaborate to establish a database of prospective clinical study participants to be evaluated for the presence of NAFLD and NASH using Owl’s noninvasive, 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 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.

Christian Weyer, MD, ProSciento.

Christian Weyer, MD, ProSciento.

“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,” says Christian Weyer, MD, president and chief development officer at ProSciento. “Owl’s lipidomics-based assays, developed and validated in sizable cohorts of biopsy-proven NAFLD/NASH patients, hold great promise as a noninvasive 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 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 of contract research organization 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.

“We are excited to join forces with ProSciento, a global leader in metabolism-focused clinical research and development that shares our deep commitment to scientific innovation in NAFLD/NASH drug development and patient care,” says Pablo Ortiz, MD, PhD, CEO at Owl. “Noninvasive 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.” 

For more information, visit Owl Metabolomics or ProSciento.