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Gilead Reports Data from the P-III (ASSURE) Trial of Seladelpar for Treating Primary Biliary Cholangitis
Shots:
- Gilead reported 2yrs. interim data from seladelpar's safety & tolerability P-III (ASSURE) study in PBC patients (n=500), enrolled in prior PBC studies (legacy studies, n=179) & P-III (RESPONSE, n=158) trial. NDA accepted for priority review by FDA (decision in Aug 2024), also accepted by MHRA & EMA for review
- The study, as of Jan 2024, showed 70% of 99 (after 24mos.) & 73% of 164 (after 12mos.) legacy patients had composite response with 42% reaching ALP normalization in each; improved pruritus with 3.8 (12mos.) & 3.1 (24mos.) pts. mean reduction in patients with baseline NRS≥4; 3.8 (6mos.) pts. in both continuous & former PBO patients across RESPONSE study
- In patients (n=102) treated for 18mos. (12mos. in RESPONSE & 6mos. in ASSURE), 62% had composite response & 33% had ALP normalization; of 29 patients on continuous 24mos. treatment, 72% & 17%, respectively, achieved the same; of 52 of them switching to seladelpar, 75% & 27% respectively, achieved it post 6mos. with 94% & 50%, respectively, achieving it post 12mos. (n=16)
Ref: Gilead | Image: Gilead
Related News:- CymaBay Reports the EMA’s Acceptance to Review the MAA of Seladelpar for Treating Primary Biliary Cholangitis (PBC)
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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.