Unmet Needs in PBC

Addressing Unmet Needs for PBC Treatment

Primary biliary cholangitis (PBC) is a chronic, destructive, autoimmune cholestatic liver disease that impairs liver function and quality of life and, even with currently available treatments, may progress to cirrhosis, liver transplantation, and death.1,2-4 Elevations in alkaline phosphatase (ALP), bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are biochemical markers associated with adverse liver-related events, liver transplantation and death.5, 6, 7 Treatment goals in both clinical research and medical management seek to lower these markers to reduce risk of disease progression.1, 7, 8, 9

Seladelpar - A Potential Option for Patients with PBC

Seladelpar is being developed as a treatment option for incomplete responders to UDCA and for high-unmet-need populations, such as those patients with moderate-to-severe pruritus, prior use of OCA and fibrates, and compensated cirrhosis.10,11,12

Taken together, these data support the potential for seladelpar to meet the needs of patients with PBC with better efficacy and tolerability than current second-line therapy.

Learn more about Seladelpar

1. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394-419.

2. EASL. J Hepatol. 2017;67(1):145-172.

3. Younossi ZM, et al. Am J Gastroenterol. 2019;114(1):48-63.

4. Lv T, et al. J Gastroenterol Hepatol. 2021;36(6):1423-1434.

5. Carbone M, Sharp SJ, Flack S, Paximadas D, Spiess K, Adgey C, et al. The UK-PBC risk scores: Derivation and validation of a scoring system for long-term prediction of end-stage liver disease in primary biliary cholangitis. Hepatology. 2016;63(3):930-50.

6. Lammers WJ, Hirschfield GM, Corpechot C, Nevens F, Lindor KD, Janssen HL, et al. Development and Validation of a Scoring System to Predict Outcomes of Patients With Primary Biliary Cirrhosis Receiving Ursodeoxycholic Acid Therapy. Gastroenterology. 2015;149(7):1804-12 e4.

7. Lammers WJ, van Buuren HR, Hirschfield GM, Janssen HL, Invernizzi P, Mason AL, et al. Levels of alkaline phosphatase and bilirubin are surrogate end points of outcomes of patients with primary biliary cirrhosis: an international follow-up study. Gastroenterology. 2014;147(6):1338-49 e5; quiz e15.

8. European Association for the Study of the Liver. Electronic address eee, European Association for the Study of the L. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-72.

9. Murillo Perez CF, Harms MH, Lindor KD, van Buuren HR, Hirschfield GM, Corpechot C, et al. Goals of Treatment for Improved Survival in Primary Biliary Cholangitis: Treatment Target Should Be Bilirubin Within the Normal Range and Normalization of Alkaline Phosphatase. Am J Gastroenterol. 2020;115(7):1066-74.

10. Hirschfield GM. Presented at: AASLD: The Liver Meeting November 13-26, 2020; Virtual.

11. Gordon SC, et al. Poster presented at: EASL: The International Liver Congress; June 23-26, 2021; Virtual.

12. Gulamhusein A, et al. Poster presented at: EASL: The International Liver Congress; June 23-26, 2021; Virtual.

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