Gilead, with approval in sight, shows $4.3B liver disease drug improves outcomes out to 2 years

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来源: FierceBiotech

The FDA is scheduled to rule on whether to approve seladelpar by mid-August.

Gilead Sciences shared more data on its $4.3 billion, near-approval liver disease prospect Wednesday, linking the candidate to sustained improvements across two years of treatment.

The molecule, seladelpar, had already moved the needle in a phase 3 trial by the time Gilead paid $4.3 billion for it and the rest of CymaBay Therapeutics earlier this year. Since then, Gilead has continued to add to the evidence in support of the PPAR-delta agonistPPAR-delta agonist in the liver disease primary biliary cholangitis (PBC), first with data from an open-label trial and now with an analysis of patients tracked for two years.

Gilead pooled participants in its phase 3 study and earlier trials to create a data set of more than 300 PBC patients for presentation at the European Association for the Study of the Liver Congress. The analysis arms Gilead with evidence of the durability of seladelpar.

Of the 99 people from earlier trials who spent 24 months on seladelpar, 70% met a composite response endpoint that looked at multiple markers of liver health. Levels of the liver damage biomarker alkaline phosphatase (ALP) normalized in 42% of participants at 24 months. The figures were similar for the 164 people in earlier studies who completed 12 months of treatment.

Gilead also reported sustained improvements in itching, a condition known medically as pruritus. The mean reduction in itch slipped slightly from 12 to 24 months, falling from 3.8 to 3.1 points between the two analyses, but still provided evidence seladelpar can address a bothersome symptom of PBC that the existing treatments are unable to manage. Gilead sees the effect on itch as a key differentiator.

“This keeps you up at night. It impacts mental health. It impacts how you work. Basically, you want to scratch your skin off,” Johanna Mercier, chief commercial officer at Gilead, said at an RBC Capital Markets event in May. “There's a real opportunity here to make a difference here with seladelpar.”

The FDA is scheduled to rule on whether to approve seladelpar by mid-August. Gilead is assuming it will receive a label in second-line for ALP normalization, positioning it to treat people who have inadequate responses to ursodeoxycholic acid.

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