CymaBay Publishes Results for Seladelpar in P-III Trial for the Treatment of Primary Biliary Cholangitis in the NEJM
Shots:
- 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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
