- 1 in 1000 women over the age of 40 lives with PBC
- The company also has clinical trials underway for NASH
CymaBay Therapeutics, Inc. (NASDAQ: CBAY), today announced that the company has initiated the seladelpar Phase 3 registration study for the treatment of Primary Biliary Cholangitis (PBC). The study is a 52-week, placEbo-coNtrolled, randomized, pHAse 3 study to evaluate the safety aNd effiCacy of sEladelpar (ENHANCE) that will be conducted in more than 20 countries spanning five continents. The study is intended to establish the efficacy and safety of seladelpar for the treatment of PBC to support the submission of a global registration dossier with health authorities to obtain approval of seladelpar. Seladelpar is a drug candidate for PBC patients who are inadequate responders to ursodeoxycholic acid (UDCA), the first line treatment of PBC, or who are intolerant to UDCA.
Pol Boudes, MD, Chief Medical Officer of CymaBay, commented, “The initiation of this Phase 3 is truly an exciting moment. I want to warmly thank all of the PBC patients who participate in our clinical studies, as well as their families and their medical teams. The data we have collected since the first PBC patient received seladelpar in December 2015 are encouraging and we believe support the potential for seladelpar to significantly improve the lives of patients with PBC. I also want to thank the CymaBay team, our advisers, and the regulators around the world who made this moment possible.”
Primary biliary cholangitis (PBC) is a serious and potentially life-threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids. There is an accompanying inflammation and destruction of the intrahepatic bile ducts, which can progress to fibrosis, cirrhosis and liver failure. Other clinical symptoms of PBC include fatigue and pruritus, which can be quite disabling in some patients. PBC is primarily a disease of women: 1 in 1000 women over the age of 40 lives with PBC.
Seladelpar is a potent, selective, orally active PPARδ agonist, currently in development for the treatment of patients with primary biliary cholangitis (PBC), an autoimmune liver disease, and with nonalcoholic steatohepatitis (NASH). Two Phase 2 studies of seladelpar established proof-of-concept in PBC. CymaBay is currently conducting a Phase 3 study of seladelpar for PBC and a Phase 2b study of seladelpar for NASH.