Gilead Sciences (NASDAQ: GILD) has announced interim results from a long-term study assessing the safety and efficacy of seladelpar, a PPAR-delta agonist, in treating pruritus associated with primary biliary cholangitis (PBC). The trial involved patients who had an inadequate response or were intolerant to ursodeoxycholic acid (UDCA), with 70% of them achieving a clinically meaningful composite response in alkaline phosphatase (ALP) and bilirubin levels, which was the primary endpoint.
The once-daily oral medication also demonstrated improvements in additional liver injury biomarkers, including total bilirubin (TB), gamma-glutamyl transferase (GGT), and alanine aminotransferase (ALT). The study reported no treatment-related serious adverse events.
As detailed in the press release, seladelpar is currently under regulatory review following Gilead’s acquisition of CymaBay Therapeutics earlier this year.- Flcube.com
