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Collaboration will help patients with liver disease, those needing biopsy
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NuSirt Biopharma and One Way Liver S.L. announced a partnership to “develop novel diagnostic tools” to advance NuSirt’s fatty liver drug research.
The collaboration is twofold: the companies will assess the feasibility of creating a one-of-a-kind liquid-biopsy companion diagnostic for the investigational fatty liver drug NS-0200 (NuSirt) and also evaluate drug-induced lipidomic changes in human trials for non-alcoholic steatohepatitis and nonalcoholic fatty liver disease, according to a press release.
“Right now the only option we have for definitive assessment of NASH — progression or regression — is liver biopsy. It’s invasive, it’s not terribly suitable for screening at-risk populations. … There’s a crying need for a liquid biopsy that would circumvent the need for [traditional] biopsy,” Michael B. Zemel, MD, chief scientific officer at NuSirt, told Healio.com/Hepatology. “We’re equally eager to have a tool that will assess early the likely responsiveness to our drug. ... Over time there’s going to be more than one, then more than two NASH drugs entering the market. It would be really quite useful to have a companion diagnostic that would help identify whether a given individual was likely to be responsive to a given drug.”
Participants enrolled in NuSirt’s phase 2 TRIPLIN clinical trial — designed to evaluate NS-0200’s efficacy in patients with NASH and NAFLD — will not only undergo MRI-estimated proton-density-fat-fraction, they will also have periodic liquid biopsy samples taken with One Way Liver S.L.’s technology.
“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,” Pablo Ortiz, MD, PhD, CEO of One Way Liver S.L., said in a press release. “We are hopeful that our novel metabolomics-based testing technology will serve as an effective surrogate marker for specific histopathological changes within the liver.” – by Janel Miller
Disclosure: Zemel is employed by NuSirt. Ortiz is an employee of One Way Liver S.L.