The latest findings from a post-hoc analysis of the phase 3 ENHANCE study were published in the journal Hepatology, CymaBay Therapeutics announced. The new data show the effect of seladelpar on serum interleukin-31 (IL-31) levels and its correlation with itching (pruritus) relief in patients with primary biliary cholangitis (PBC).
“Pruritus is a debilitating symptom for many people living with PBC, yet the underlying mechanism of itch is not well understood,” said Andreas Kremer MD, Ph.D., MHBA, Professor and Head of Hepatology, University Hospital Zurich and primary author of the study.
“These latest data are critical in advancing our understanding of potential mediators of cholestatic itch and suggest that IL-31 may have a role in driving pruritis in people with PBC. While current treatments for cholestatic pruritus remain limited, these data can help inform potential novel therapeutic approaches.”
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The analysis evaluated the IL-31 serum levels in patients with PBC who received daily oral doses of seladelpar for three months. A total of 53 patients received 5 mg of the investigational drug, 53 patients received 10 mg, and 55 received placebo.
Treatment with the 5 mg dose caused a statistically meaningful decrease in the level of IL-31 compared with placebo. IL-31 levels correlated with pruritus intensity, which was assessed using a numerical rating scale of one to ten.
Moreover, those who experienced pruritus relief evidenced by a decrease of two or more on the numerical rating scale also had greater reductions in IL-31 compared to patients who did not experience changes in pruritus intensity.
The levels of IL-31 at the start of the study correlated with the levels of total and conjugated bile acids. Bile acids are powerful molecules produced by the liver to help the digestion of fats. They undergo a chemical reaction in the liver cells, called conjugation, quickly after being produced.
Strong correlations were also observed between changes in IL-31 levels and changes in total bile acids and conjugated bile acids in the group of patients who received 10 mg of seladelpar.
