FOSTER CITY (dpa-AFX) - Gilead Sciences, Inc. (GILD) announced Tuesday positive results from a Phase 3 study in people with primary biliary cholangitis (PBC), showing that treatment with Livdelzi (seladelpar) led to significantly more patients achieving normalization of alkaline phosphatase (ALP).
ALP is a key liver marker of disease progression, compared with placebo after 52 weeks. The primary endpoint was defined as a composite of ALP - 1.0× upper limit of normal (ULN) and a - 15% decrease from baseline.
These findings were observed in people with inadequately controlled disease, defined as having ALP levels above the ULN and below 1.67×ULN, with an incomplete response or intolerance to ursodeoxycholic acid (UDCA).
The safety profile of seladelpar observed in IDEAL was consistent with previously reported Livdelzi studies, with no new safety concerns identified.
In PBC, ALP is a key disease marker associated with disease activity and long-term outcomes. ALP levels above normal, including in the 1.0 to 1.67×ULN range, are associated with increased risk of progression to liver transplant or death compared with normalized ALP levels.
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