ProSciento and OWL Metabolomics announced an exclusive, long-term partnership to identify eligible participants for clinical trial enrollment to evaluate therapeutic candidates for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), two common liver conditions.
Together, the two companies will establish a database of prospective clinical trial participants specifically for NAFLD and NASH, leveraging OWL’s non-invasive, lipidomics-based blood tests that are an alternative to invasive liver biopsies.
“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,” Christian Weyer, MD, ProSciento’s president and chief development officer, said in a press release.
“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,” he added. “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 over 30,000 active study participants for diabetes, obesity, and related metabolic conditions. Additionally, ProSciento has access to more than 900,000 study participants through its current network of study sites.
The partnership aims to accelerate patient enrollment and reduce screen failure rates in clinical trials. Efforts will start at ProSciento’s early phase clinical research unit and then expand within the company’s network of metabolism-focused study sites. OWL also will join ProSciento’s clinical research innovation (CRI) partner network to support and accelerate metabolic drug development.
“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,” added Pablo Ortiz, MD, PhD, OWL’s chief executive officer.
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