Gilead Sciences, Inc. (NASDAQ) on Tuesday released results from the Phase 3 IDEAL study in people with primary biliary cholangitis (PBC).

The study showed that treatment with Livdelzi (seladelpar) resulted in significantly more patients achieving normalization of alkaline phosphatase (ALP), a key liver marker associated with disease progression, compared with placebo after 52 weeks.

The primary endpoint was defined as a composite of ALP ≤1.0× the upper limit of normal (ULN) and a ≥15% decrease from baseline.

Results Support Use In Underrepresented PBC Patient Population

The 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).

This patient population has been underrepresented in previous randomized trials despite being commonly encountered in clinical practice.

The safety profile of seladelpar observed in the IDEAL study was consistent with previously reported Livdelzi ...