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Intercept to collaborate with UPenn for new research on obeticholic acid, chronic liver diseases
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Intercept Pharmaceuticals Inc. announced it has launched a new research initiative with the University of Pennsylvania’s PennCHOP Microbiome Program, a collaboration between the Perelman School of Medicine at the University of Pennsylvania and the Children's Hospital of Philadelphia, to evaluate the safety and efficacy of obeticholic acid in various chronic liver diseases, according to a press release.
The collaboration will begin with PennCHOP researchers, including Gary Wu, MD, professor of gastroenterology at the Perelman School of Medicine, and co-director of the PennCHOP Microbiome Program, analyzing samples from the phase 3 REGENERATE trial, in which patients with nonalcoholic steatohepatitis and fibrosis have been dosed with obeticholic acid (OCA), a bile acid analog and first-in-class agonist of the farnesoid X receptor. The goal is to determine the efficacy and safety of the drug and what impact it has on the microbiota in the gastrointestinal tract, according to the release.
“This collaboration with Intercept, which gives us access to patient samples and data from the largest NASH clinical program to date, is anticipated to provide new insights into the relationship between gut microbiota, NASH and a modified bile acid like OCA,” Wu said in the release. “It also opens the door to future research in diseases such as primary sclerosing cholangitis and primary biliary cholangitis.”
"The PennCHOP program is at the forefront of microbiome research … this is an exciting area of emerging research and we are committed to determining how OCA’s interaction with the gut-liver axis may help patients with NASH and other non-viral liver diseases,” David Shapiro, MD, chief medical officer and executive vice president of development at Intercept, said in the release.
The collaboration is expected to last 7 years and will included analyses of additional patient samples in other chronic liver diseases, according to the release.
Disclosure: Wu reports receiving honoraria from Intercept. Shapiro is employed by Intercept.