Benzinga | Aug 3, 2020 07:07AM EDT

CymaBay Calls Topline Results from its ENHANCE Study for Seladelpar in Patients with Primary Biliary Cholangitis 'Positive'

* The study demonstrated seladelpar to be efficacious, safe and well-tolerated

* 78.2% of patients on seladelpar 10 mg versus 12.5% on placebo achieved the primary composite outcome after only 3 months (p<0.0001)

* 27.3% of patients on seladelpar 10 mg versus zero on placebo normalized ALP by 3 months (p<0.0001)

* Statistically significant improvement in pruritus (p<0.05) for patients with moderate-to-severe itch demonstrated for seladelpar 10 mg versus placebo

* Strongly supports re-initiation of Phase 3 study to confirm the potential of seladelpar to be a best-in-class treatment for PBC

* Conference call today at 8:00 a.m. ET