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Two new phase III trials show that elafibranor and seladelpar — both accelerated-approval drugs for primary biliary cholangitis (PBC) — can normalize alkaline phosphatase (ALP) levels in the vast majority of patients who didn't fully respond to first-line therapy. The ELSPIRE trial showed 85.3% normalization with elafibranor vs. 23.3% with placebo, while the IDEAL trial showed 75.4% with seladelpar vs. 16.1% with placebo. Researchers say biochemical normalization is now a "feasible goal."
Two phase III trials presented at the AASLD annual meeting in Denver are giving clinicians more confidence in two recently accelerated-approved drugs for primary biliary cholangitis (PBC). Both elafibranor (Iqirvo) and seladelpar (Livdelzi) demonstrated striking rates of alkaline phosphatase (ALP) normalization in patients who had an incomplete response or intolerance to first-line therapy with ursodeoxycholic acid (UDCA).
The ELSPIRE trial focused on an understudied "intermediate" group — patients with ALP above the upper limit of normal (ULN) but below the 1.67x ULN threshold traditionally used to define poor outcomes. Even in this earlier-stage population, elafibranor delivered strong results, with researchers noting that starting treatment earlier in the disease course could maximize normalization rates. The IDEAL trial similarly showed seladelpar's effect kicking in as early as one month into treatment.
By the Numbers:
Why it matters: ALP normalization is strongly linked to better long-term liver outcomes in PBC. These trials confirm that achieving full biochemical normalization — not just partial response — is a realistic treatment target, potentially reshaping how clinicians approach PBC management.
