Gilead shares results from two-year analysis of phase 3 study in primary biliary cholangitis
Betsy Goodfellow | June 5, 2024 | News story | Research and Development | Gilead, Hepatology, clinical trials, primary biliary cholangitis, seladelpar
Gilead has announced two-year interim results from the ongoing ASSURE study of investigational seladelpar for the treatment of primary biliary cholangitis (PBC).
The two-year analysis includes patients living with PBC who have participated in any previous clinical studies of seladelpar as well as participants from the pivotal phase 3 RESPONSE study.
Results have demonstrated ‘rapid and sustained improvements in markers of cholestasis, including high rates of normalisation of liver biomarkets and a clinically meaningful reduction in pruritus’, according to the press release.
These results have been shared in a presentation during the European Association for the Study of the Liver (EASL) Congress 2024, held in Milan, Italy.
Timothy Watkins MD MSc, vice president of clinical development of inflammation therapeutics at Gilead Sciences, commented: “The data presented at EASL further supports the sustained efficacy and safety profile of seladelpar observed across its robust development programme, including a capacity to normalise ALP values for many of the people studied with PBC. Given ALP is recognised as an important surrogate marker of disease progression in PBC, providers are shifting to normalisation as a treatment goal, which could potentially be enabled by seladelpar, if approved. Seladelpar is a potential best-in-class therapy that could transform the treatment landscape for people living with PBC by not only improving or even normalising markers of liver function, but also improving pruritis or itch. Pruritis is a particularly burdensome symptom of PBC which can significantly disrupt a person’s quality of life. We’re committed to transforming the management of PBC and the lives of those impacted by this rare disease as we work together to bring seladelpar to the community, if approved.”
Betsy Goodfellow
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