Phase 10 score sheet11/25/2023 ![]() ![]() "The results further support seladelpar's recently revised Breakthrough Therapy Designation, which was expanded to include pruritus and compensated cirrhosis. "Among the most encouraging findings in this study are the rapid, sustained, and durable improvements we're seeing with seladelpar in treating cholestasis and liver injury, as well as its significant impact on itch for patients over the 12 months of the study," said Gideon Hirschfield, M.D., Lily and Terry Horner Chair in Autoimmune Liver Disease Research, Toronto Centre for Liver Disease. A statistically significant reduction in pruritus was also observed at Month 6 and at Month 12 for patients in the intent-to-treat population, which includes all patients irrespective of their NRS score at baseline. Approximately 37.3% of patients enrolled had moderate-to-severe pruritus based on an NRS (0-10) score ≥ 4 at baseline. Notably, these improvements were sustained through Month 12 (p<0.005). ![]() 20.0% of patients on placebo (p 4 reporting decreases of 3.2 points with seladelpar (n=65) vs. 61.7% of patients on seladelpar 10 mg achieved the primary composite endpoint vs. ![]()
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