Sunday, June 23, 2024
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Gilead Sciences, after acquiring CymaBay Therapeutics, has announced interim findings from the ongoing ASSURE study, indicating positive outcomes with seladelpar treatment for primary biliary cholangitis (PBC). The results demonstrate improvements in cholestasis markers, reduced inflammation, and notably, alleviation of pruritus (itch) in individuals with PBC, an area lacking specific treatment options. These findings will be presented at the Digestive Disease Week® 2024 Conference in Washington, DC.

The ASSURE study assesses the safety and efficacy of seladelpar, a peroxisome proliferator-activated receptor (PPAR) delta agonist, in adults with PBC who had an inadequate response or intolerance to ursodeoxycholic acid (UDCA). The interim analysis included 174 patients, the majority of whom were female (94%) with a mean age of 59 years. Key baseline characteristics showed elevated alkaline phosphatase (ALP) levels and total bilirubin (TB) levels, with 19% of patients meeting cirrhosis criteria.

Results indicated significant improvements in biochemical endpoints, including ALP normalization, ALP reduction, and decreased TB levels. Seventy percent of patients completing 12 months of seladelpar treatment achieved a clinically meaningful composite response, with 37% experiencing ALP normalization and a notable mean ALP reduction from baseline. Similar positive trends were observed in patients completing 24 months of treatment.

Seladelpar also demonstrated a favorable safety profile, with no treatment-related serious adverse events reported. Most patients tolerated the treatment well, with a low discontinuation rate due to adverse events.

These interim findings suggest that seladelpar holds promise as a potential therapeutic option for individuals with PBC, offering improvements in liver function and pruritus reduction. Further evaluation through ongoing studies will provide additional insights into its long-term safety and efficacy.

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