CymaBay's New Seladelpar Two-Year Data Shows Improved Transplant-Free Survival

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.