CymaBay Therapeutics Publishes P-III Study (ENHANCE) Results of Seladelpar for the Treatment of Primary Biliary Cholangitis in Hepatology
Shots:
- The P-III study evaluating seladelpar (selective PPARδ agonist) vs PBO in patients with PBC. The composite EPs were achieved in 78.2% & 57.1% of patients on seladelpar (10 & 5mg) vs 12.5% on PBO while the 2EPs were met of having normal levels of alkaline phosphatase in 27.3% & 5.4% vs none in PBO group, respectively.
- The final key 2EPs assessed the patient-reported symptom of pruritus using a daily pruritus NRS, improving pruritus for patients with mod.-to-sev. itch (NRS ≥4) & also had improvements in markers of liver injury & no treatment-related adverse EPs were reported in the study
- Seladelpar is currently being studied in the P-III registration study (RESPONSE) for PBC & the results are expected in Q3’23
Ref: Globenewswire | Image: CymaBay Therapeutics
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