- CymaBay Therapeutics Inc's CBAY results from new analyses of clinical studies of seladelpar were presented during Digestive Disease Week (DDW).
- Data demonstrated that seladelpar treatment decreased Primary Biliary Cholangitis (PBC) GLOBE score and predicted improved transplant-free survival throughout two years.
- The GLOBE score is a risk assessment tool providing an estimate of transplant-free survival for patients with PBC.
- In this analysis, the GLOBE score was used to measure response to seladelpar treatment for predicting long-term survival outcomes for patients with PBC.
- Treatment of 50 patients with oral seladelpar 5 mg or 10 mg daily for two years resulted in a mean (SD) change from baseline in GLOBE score of -0.417 (0.269).
- However, an analysis of subpopulations of high-risk patients by GLOBE score (> 0.3) revealed that while patients of all ages improved, the younger patients tended to have numerically greater improvements, although these differences did not achieve significance.
- The results from a pooled analysis of Phase 2 and Phase 3 studies, at 3 months, showed that seladelpar treatment led to reductions in ALP of -31% and -41%, respectively, with a -2.6% change placebo-treated patients.
- A change in ALT of up to -32% was observed (10 mg seladelpar group) while bilirubin, platelets, albumin, and INR remained stable.
- Price Action: CBAY shares are down 3.81% at $2.02 during the market session on the last check Monday.
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