Gilead announces data from interim analysis of Phase 3 ASSURE study

Gilead (GILD) Sciences announced data from a two-and-a-half-year interim analysis from the ongoing Phase 3 ASSURE study, which showed that 81%, or 30 out of 37, of participants with primary biliary cholangitis, or PBC, treated with Livdelzi achieved a composite biochemical response, demonstrating significant improvements in a key measures of PBC progression. Additionally, 41%, or 15 out of 37, of participants achieved normalization of alkaline phosphatase, or ALP, levels, a critical biomarker of liver function. These findings were unveiled as a late-breaker presentation at The Liver Meeting 2024 hosted by the American Association for the Study of Liver Diseases, or AASLD. “Gilead has a legacy of bringing groundbreaking treatments to people in need and Livdelzi is the first and only treatment to demonstrate statistically significant and durable improvements in both pruritus and markers of cholestasis related to the risk of disease progression,” said Timothy Watkins, MD, MSc, Vice President, Clinical Development, Inflammation Therapeutics, Gilead Sciences. “With Livdelzi, we’ve introduced an effective and well tolerated option for people living with PBC, offering an important novel treatment option. We remain committed to advancing innovative therapies that provide real hope and improved outcomes for people facing this challenging liver disease.”