Company announces positive results from the ENHANCE Global Phase 3 Study of seladelpar for primary biliary cholangitis
Results show that after 3 months, 78.2% of patients on seladelpar 10 mg vs 12.5% on placebo achieved the primary composite outcome of alkaline phosphatase (ALP) <1.67x upper limit of normal (ULN), ALP decrease ≥15% and total bilirubin ≤ULN at month 12 (p<0.0001).
Source:
Biospace Inc.
SPS commentary:
Seladelpar is a selective, orally active PPARδ agonist that has been in development for the treatment of primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). For PBC, it has received an orphan designation from FDA and European Medicine Agency (EMA). It has also received Breakthrough Therapy Designation from FDA for early stage PBC and Priority Medicine status from EMA.