VIDEO: Seladelpar effective for PBC, to be studied in NASH
VIENNA — In this exclusive video from the International Liver Congress 2019, Sujal Shah, MS, MBA, president and CEO of CymBay Therapeutics, discusses the results of a phase 2 study presented at the meeting as well as other studies currently in the midst of enrolling patients.
“The data [at the International Liver Congress] demonstrates additional data sets that show effects as well as safety overall being comparable for patients with [primary biliary cholangitis] who are non-cirrhotic as well as those that have compensated cirrhosis,” Shah told Healio Gastroenterology and Liver Disease. “The breadth of data that we have shared at multiple meetings over the past 2 years in fact has supported breakthrough therapy designation as well as prime designation for seladelpar [CymBay Therapeutics] in the setting of PBC and also supported a global phase 3 registration study that is now enrolling patients that are either inadequate responders to [ursodeoxycholic acid] or intolerant to UDCA.”
Shah said that the ENHANCE trial, which will take place in 150 sites across 25 countries, has begun enrolling patients, and that the company hopes to finish enrollment by the end of 2019 and present data in early 2021 about seladelpar’s therapeutic effect in PBC.
Disclosure: Shah is an employee of CymBay Therapeutics