Gilead’s Phase 3 IDEAL Study Shows Livdelzi Superior to Placebo on ALP Normalization in Mildly Elevated PBC Patients
Gilead Sciences released Phase 3 IDEAL study data showing Livdelzi achieved statistically significant ALP normalization versus placebo after 52 weeks in patients with inadequately controlled primary biliary cholangitis.
finance.yahoo.comGilead Sciences, Inc. released results from the Phase 3 IDEAL study on Tuesday showing that Livdelzi (seladelpar) produced more patients achieving normalization of alkaline phosphatase compared with placebo after 52 weeks. 0 times the upper limit of normal and a reduction of at least 15 percent from baseline.
67 times that limit despite an incomplete response or intolerance to ursodeoxycholic acid. This population has been underrepresented in prior randomized trials even though it is commonly seen in clinical practice. Benzinga reported the findings support potential use of Livdelzi in this group.
The safety profile of seladelpar in the IDEAL study was consistent with previously reported Livdelzi data.
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