Male liver anatomy
Illustration of male liver anatomy

Metabolomics and liver disease diagnostics company One Way Liver S.L. (OWL Metabolomics) has begun a strategic partnership with NuSirt Biopharma to develop novel diagnostics tools for NuSirt’s fatty liver drug candidate, NS-0200.

Under the collaboration, OWL and NuSirt will evaluate drug-induced lipidomic changes in human trials for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) and explore the potential of developing a unique liquid-biopsy companion diagnostic (CDx) for NS-0200.

“Newly developed drugs are becoming more targeted and personalized for prevalent diseases, and regulatory authorities are seeking more precise technologies in evaluating the effects of early-stage drug candidates and determining the most appropriate patient selection,” said Pablo Ortiz, M.D., Ph.D., CEO of OWL. “We are hopeful that our novel metabolomics-based testing technology will  serve as an effective surrogate marker for specific histopathological changes within the liver and help enhance the care of NASH patients and the development of effective medical therapies to treat their condition.”

According to company documents, NuSirt considers NS-0200 to be the company’s highest priority for advancing through clinical trials. It commenced a Phase IIa trial last November evaluating two doses of the combination vs. placebo in patients with NAFLD and in December received FDA Fast Track designation for the drug candidate for the treatment of NAFLD/NASH. In a conference call in February, company management asserted that should NS-0200 gain marketing approval, it would likely become the preferred therapy earlier in the course of fatty-liver disease as it addresses all three core conditions in NASH— increased liver fat, inflammation, and fibrosis—while competing drug candidates addressed two, at most.

“Millions of people have NAFLD/NASH, but there are few medical therapies available to treat them,” said Joe C. Cook, Jr., executive chairman and president of NuSirt Biopharma. “OWL is a leader in diagostics for liver diseases, and we are delighted to partner with its team to not only investigate our own potential new treatment, but also examine how molecular diagnostics could broadly advance the diagnosis, treatment, and monitoring of these diseases.”

The collaboration with Spain-based OWL should help speed the clinical trials for NuSirt. The company’s serum-based diagnostic tests, OWL Liver and OWL Liver Care assays are the world's first patented metabolomics-based in vitro tests for diagnosing NASH and hepatic steatosis (NAFLD), respectively, using micro-blood samples (<0.5 mL). This provides for the earlier detection of these diseases, and will allow NuSirt to delay invasive—and risky—liver biopsies of NS-0200 trial participants until Phase III. Further, the serum-based approach will allow the two companies to develop a liquid biopsy companion diagnostic for the two conditions to allow for earlier detection and a more effective treatment of the disease.

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