CymaBay Publishes on Phase 2 Study of Seladelpar in Primary Biliary Cholangitis

 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced that results from the Phase 2, 52-week study of seladelpar in patients with primary biliary cholangitis (PBC) have been published in the Journal of Hepatology:

Bowlus CL, Galambos MR, Aspinall RJ, Hirschfield GM, Jones DEJ, Dörffel Y, Gordon SC, Harrison SA, Kremer AE, Mayo MJ, Thuluvath PJ, Levy C, Swain MG, Neff GW, Sheridan DA, Stanca CM, Berg CP, Goel A, Shiffman ML, Vierling JM, Boudes P, Steinberg A, Choi YJ, McWherter CA, A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis, Journal of Hepatology (2022), doi: https://doi.org/10.1016/j.jhep.2022.02.033.

This 52-week, phase 2, dose-ranging, open-label study examined the efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-delta agonist, in adults with PBC who were receiving or intolerant to first-line therapy with ursodeoxycholic acid. Eligible patients were enrolled with a minimum serum alkaline phosphatase (ALP) levels of 1.67 times the upper-limit-of-normal (194 U/L) and which were on average in excess of 318 U/L. Seladelpar was administered orally once daily at 2 mg (n=11), 5 mg (n=53) or 10 mg (n=55) for 12 weeks, after which doses could be increased up to 10 mg if needed to improve treatment response. Cirrhosis was present in 21% of patients; 71% had pruritus.

An interim primary efficacy analysis of ALP change from baseline at Week 8 found that seladelpar treatment provided 26%, 33%, and 41% reductions for the 2 mg, 5 mg and 10 mg doses, respectively (all p<0.005). Responses were maintained or improved at Week 52 which included dose escalation in 91% and 80% of the 2 mg and 5 mg cohorts, respectively. At Week 52, the composite biochemical response (ALP <1.67×ULN, ≥15% ALP decrease from baseline, and normal total bilirubin) rates were 64%, 53%, and 67%, and ALP normalization rates were 9%, 13%, and 33% in the 2 mg, 5 mg, and 10 mg cohorts, respectively. The pruritus visual analog scale score was also decreased in the 5 mg and 10 mg cohorts. There were no treatment-related serious adverse events (AEs), and 4 patients discontinued due to AEs.

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