The CDRH’s plans for the communications pilot were based on public feedback received over the course of the psat few years. Image credit: Tada Images / Shutterstock.

The US Food and Drug Administration (FDA) has awarded Oxford, UK-based imaging diagnostic company Perspectum a Drug Development Tool (DDT) grant of almost $250,000 to further its research into the development of a novel biomarker for rare disease primary sclerosing cholangitis (PSC).

PSC is a rare chronic and progressive cholestatic liver disease that causes bile ducts in and outside of the liver to become inflamed and scarred, and eventually narrowed or blocked. No cure exists for PSC, and there are currently no effective pharmacotherapies approved for use by the FDA. While rare, with estimates that the disease affects around 30,000 individuals in the US, the condition is one of the leading drivers of liver transplant. 

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The FDA funding is expected to support Perspectum’s research in partnership with the Consortium for Autoimmune Liver Disease (CALiD), which is currently focused on investigating the efficacy of a novel biomarker that the companies say has shown promise in preliminary research for PSC.

Professor Christopher Bowlus, chief of the Division of Gastroenterology and Hepatology at UC Davis Health and chair of CALiD said that with the FDA’s support, the companies aim to explore the potential of quantitative magnetic resonance cholangiopancreatography (MRCP) as a monitoring biomarker in PSC.

A procedure most commonly used to determine whether gallstones are lodged in any of the ducts surrounding the gallbladder, MRCP presents a non-invasive approach towards visualising the biliary and pancreatic ducts.

“Leveraging the CALiD database, one of the largest PSC patient databases in North America, we plan to study at least 150 patients with serial MRCP+ reports, linking changes in MRCP+ to clinical outcomes,” Bowlus explained.

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“If successful, this could lay the foundation for a non-invasive, reliable biomarker recognised within the FDA Biomarker Qualification Program, improving patient care and serving as an essential tool in clinical trials to bridge the current gap in drug development.”

Perspectum spun out from the University of Oxford in 2012. In 2023, the company raised $55m in a Series C funding round led by Oppenheimer Holdings, taking its total funding to date to $60m, as per GlobalData’s deals database.