Seladelpar – Phase 2 results published
“This study demonstrates the significant anticholestatic effects of seladelpar in patients with PBC who had suboptimally responded to UDCA or were UDCA intolerant. Evidence of seladelpar’s dose-dependent efficacy, safety, and improvement in patient-reported pruritus was substantial and durable. Biochemical improvement and safety were generally similar in patients with and without cirrhosis. Significant reductions in mean ALP levels were observed in all cohorts as early as 3 months, with a 43% reduction from baseline and normalization of ALP in 31% of patients in the 10 mg cohort. ALP reductions, an evidence-based surrogate for long-term transplant-free outcomes were maintained through 1 year in patients in the 10 mg cohort”…Read full study.