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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