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CymaBay Announces Oral Late-Breaking Presentation of Interim Results from an Ongoing Phase 2 Study of Patients with Primary Biliary Cholangitis at the AASLD 2017 Liver Meeting

1 week ago

– Interim phase 2 study results demonstrate the potential for superior efficacy and better tolerability over existing second-line therapy

– CymaBay will also present new clinical research on pruritus, a symptom frequently affecting the quality of life for patients with primary biliary cholangitis

– Company will host Post-AASLD Key Opinion Leader lunch for the investment community on October 25 in New York

NEWARK, Calif., Oct. 09, 2017 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (CBAY), today announced that a late-breaking presentation describing results from a pre-planned interim analysis from its ongoing phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC) will be delivered at The Liver Meeting® hosted by the American Association for the Study of Liver Diseases (AASLD) in Washington D.C. (October 20-24, 2017).  Seladelpar is an orally administered, potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in development for PBC and nonalcoholic steatohepatitis (NASH).

The abstract, entitled “Treatment efficacy and safety of low dose Seladelpar, a selective PPAR-δ agonist, in patients with primary biliary cholangitis: twelve-week interim analysis of an international, randomized, dose ranging, phase 2 study” is published on the AASLD website1. The oral presentation will be made on October 23 by Professor Gideon Hirschfield from the Center for Liver Research of the University of Birmingham in the U.K.

“We are very pleased to have been granted a late-breaking presentation at the prestigious annual AASLD Liver Meeting for the second straight year. These data further the dose-ranging evaluation for seladelpar in patients with PBC and allow us to start planning of our phase 3 program,” said Dr. Pol Boudes, M.D., Chief Medical Officer of CymaBay. “The opportunity to present these results allows CymaBay to recognize the commitment of patients who participated in our studies and thank them for their dedication and contribution to the PBC community. We also want to thank our investigators and their coordinators.”

CymaBay will also present the clinical evaluation of pruritus in PBC. These results support the use of the pruritus Visual Analog Scale, a patient-reported outcome, as a convenient and reliable clinical research tool. The abstract1 titled “Concordance of pruritus scales in primary biliary cholangitis (PBC) patients: Pruritus visual analogue scale (VAS) and 5-D itch scale in clinical trial settings” will be presented on October 20 by Dr. Alexandra Steinberg, M.D., Ph.D., Medical Director of CymaBay.

Dr. Steinberg added, “We have a core mission to advance medical knowledge and to share what we learn in order to improve patient care. Pruritus is an important symptom of PBC and evaluating the reliability of tools for its evaluation is necessary in order to integrate their use into our clinical programs.”

CymaBay plans to hold additional meetings during and post The Liver Meeting® featuring discussions with investigators and key opinion leaders involved in the treatment of patients with PBC:

  • October 22, 2017 – CymaBay Investigator Study Update Luncheon.  This event is open to investigators and coordinators involved in the ongoing phase 2 study of seladelpar in patients with PBC by invitation from CymaBay.
  • October 25, 2017 – Key Opinion Leader Lunch: Post-AASLD Review of Novel Treatments for Primary Biliary Cholangitis (PBC) featuring Professor Gideon Hirschfield from the Center for Liver Research of the University of Birmingham in the U.K.  This event will take place at the Lotte New York Palace in New York City from 12:00pm to 1:30pm ET and is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance to contact@lifesciadvisors.com if you plan to attend, as space is limited.

1 https://www.aasld.org/events-professional-development/liver-meeting/presenters/abstracts

About PBC 
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.

About Seladelpar 
Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases PBC and NASH. For PBC, seladelpar has received an orphan designation from the US Food and Drug Administration and the European Medicine Agency. Seladelpar also received the PRIority MEdicine (PRIME) status from the European Medicine Agency.

About CymaBay 
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. Seladelpar is a potent and selective agonist of PPARδ, a nuclear receptor that regulates genes involved in bile acid/sterol, lipid and glucose metabolism and inflammation. Seladelpar is currently in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Two phase 2 studies of seladelpar established proof of concept in PBC. CymaBay is currently planning to advance development of seladelpar into phase 3 for PBC and phase 2 for NASH. Arhalofenate is a potential urate-lowering anti-flare therapy that 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.

Contact:               
Sujal Shah
CymaBay Therapeutics, Inc.
(510) 293-8800
Investors@CymaBay.com

Hans Vitzthum
LifeSci Advisors, LLC
212-915-2568
Hans@LifeSciAdvisors.com

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