Seladelpar Data

Initial Clinical Study Results With Seladelpar Demonstrate Improved Biochemical Response and Pruritus

Seladelpar is being studied in a comprehensive PBC clinical development program that has included more than 400 patients with an incomplete response or intolerance to ursodeoxycholic acid (UDCA) treatment, with many patients receiving seladelpar for more than two years.^1,2-4 Data from these trials suggest that seladelpar may optimize patient treatment response by:

Increasing rates of normalization of ALP, bilirubin and ALT
Relieving pruritus, and
Providing a safe treatment option for the broad PBC population, including patients with compensated cirrhosis.^1,5,7
Appearing to be safe and well tolerated with low discontinuation rates due to adverse events

References

^{1. Bowlus CL, et al. J Hepatol. Published online March 30, 2022. doi:10.1016/j.jhep.2022.02.033.}

^{2. Jones D, et al. Lancet Gastroenterol Hepatol. 2017;2(10):716-726.}

^{3. CymaBay Therapeutics, Inc. Press Release. https://ir.cymabay.com/press-releases/detail/486/cymabay-announces-positive-topline-results-from-enhance-for-seladelpar-in-patients-with-primary-biliary-cholangitis. Published August 3, 2020. Accessed December 31, 2021}

^{4. CymaBay Therapeutics, Inc. Data on file [PBC Pathology Virtual Advisory Board – December 1, 2021].}

^{5. Mayo MJ, et al. Presented at: AASLD: The Liver Meeting; November 12-15, 2021; Virtual.}

^{6. Hirschfield GM. Presented at: AASLD: The Liver Meeting November 13-26, 2020; Virtual.}

^{7. Kremer AE, et al. Liver Int. 2022;42(1):112-123.}

Initial Clinical Study Results With Seladelpar Demonstrate Improved Biochemical Response and Pruritus

References

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