CymaBay to Present Data from its Phase 2 Proof-of-Concept Study of Seladelpar in Patients With Primary Biliary Cholangitis at the EASL Liver Meeting 2017
NEWARK, Calif., April 13, 2017 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for specialty and orphan diseases with high unmet medical need, today announced that data from its Phase 2 proof-of-concept study of seladelpar in patients with primary biliary cholangitis (PBC) will be presented at the International Liver CongressTM 2017 sponsored by the European Association for the Study of Liver Diseases (EASL), in Amsterdam, The Netherlands, April 19-23 2017. Seladelpar is an orally administered potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist.
|Title:||Proof of efficacy for seladelpar, a selective PPARδ agonist, in patients with primary biliary cholangitis non-responsive to ursodeoxycholic acid: results of an international Phase 2 randomised controlled clinical study|
|Session:||Oral ePosters, Autoimmune and cholestatic liver disease (clinical)|
|Date:||April 22, 2017|
|Time:||13:00 – 14:00|
|Location:||Poster Booth 1 (Hall 1)|
|Authors:||G.M. Hirschfield, M.R. Galambos, C.L. Bowlus, M.G. Swain, Y. Doerffel, A.S. Steinberg, M. Varga, Y.-J. Choi, R.L. Martin, H. Chera, C.A. McWherter, P.F. Boudes, and D. Jones for the MBX8025-21528 Study Investigators|
”We are very pleased that EASL has selected our clinical work on seladelpar to be presented at the premier international hepatic congress. This provides us a great opportunity to present new data concerning the mechanism of action of seladelpar to improve the cholestasis affecting patients with PBC,” said Pol Boudes, MD, Chief Medical Officer of CymaBay Therapeutics. Dr. Boudes added, “We are truly grateful to our investigators and their patients and want to thank them for their invaluable contribution.”
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, afflicting approximately one in 1,000 over the age of 40.
Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases PBC and NonAlcoholic SteatoHepatitis (NASH). For PBC, seladelpar has received an orphan designation from the US Food and Drug Administration and the PRIority Medicine (PRIME) status from the European Medicine Agency.
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company focused on developing therapies for specialty and orphan diseases with high unmet medical need. Seladelpar is a potent, selective, orally active PPARδ agonist. A Phase 2 study of seladelpar in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile. CymaBay has completed Phase 2 studies for seladelpar in subjects with primary biliary cholangitis and homozygous familial hypercholesterolemia, establishing proof-of-concept in both indications. Arhalofenate is a potential Urate-Lowering Anti-Flare Therapy that has completed five Phase 2 studies in subjects with gout. Arhalofenate has been found to reduce painful flares in joints while at the same time lowering serum uric acid by promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia. Arhalofenate has been licensed in the U.S. to Kowa Pharmaceuticals America, Inc. CymaBay retains full development and commercialization rights for arhalofenate outside the U.S.
For additional Information about CymaBay visit www.cymabay.com.