The P-III (RESPONSE) study evaluates Seladelpar (10mg, QD) vs PBO in PBC patients (n=193, in ratio 2:1) with an inadequate response or intolerance to UDCA. The 1EP was a composite of ALP & total bilirubin at 12mos. & 2EPs were ALP normalization & change in patient-reported pruritus
The 1EP of the study was met in 61.7% vs 20% of patients & 2EP of ALP normalization was met in 25% vs 0% of patients, avg. decrease in ALP was 42.4% vs 4.3%, ALT & GCT was reduced by 23.5% vs 6.5% & 39.1% vs 11.4% at 12mos.
Of the evaluable patients, 37.3% had moderate-to-severe pruritus with NRS score ≥4 at baseline, improvement was seen at wk.4 & significance was achieved at 6mos. with a reduction in points by 3.2 vs 1.7
Ref: CymaBay Therapeutics | Image: CymaBay Therapeutics
Related News:- CymaBay Therapeutics Publishes P-III Study (ENHANCE) Results of Seladelpar for the Treatment of Primary Biliary Cholangitis in Hepatology
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