Results from the RESPONSE registrational study to be highlighted in oral presentation on
Fifth oral late-breaking presentation of seladelpar results at The Liver Meeting®
The oral presentation titled “Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis in the RESPONSE Trial: A Phase 3 International, Randomized, Placebo-Controlled Study,”1 will be delivered by Professor
Additionally, a poster presentation2 will highlight the comparison of the serum metabolomes of patients with PBC to matched healthy volunteers and a second poster presentation3 will evaluate seladelpar’s activity in a pre-clinical model of human PBC.
Presentations at the Liver Meeting® 2023 include:
Late-Breaking Oral Presentation:
1“Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis in the RESPONSE Trial: A Phase 3 International, Randomized, Placebo-Controlled Study” (Abstract #5002)
Poster Presentations:
Monday, November 8:00 –
2“Widespread Dysregulation of Metabolic Stress Pathways is a Characteristic of Primary Biliary Cholangitis (PBC): Comparison of the Serum Metabolomes of PBC Patients to
3“Seladelpar Activity in a Pre-Clinical Model of Human PBC” (Abstract #4573-C)
A full list of presentations can be found on The Liver Meeting® 2023 website.
The presentations will also be made available on the CymaBay website.
About PBC
PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the US). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of ALP and total bilirubin. The most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality.
About Seladelpar
Seladelpar, an investigational treatment for people with PBC, is a first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, or delpar, shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need. Preclinical and clinical data support its ability to regulate genes involved in bile acid synthesis, inflammation, fibrosis and lipid metabolism, storage, and transport.
About CymaBay
Cautionary Statements
Any statements made in this press release regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms or outcomes of the disease, the potential benefits to patients and the future filing and commercialization plans of CymaBay are forward-looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; and effects observed in trials to date that may not be repeated in the future. Additional risks relating to CymaBay are contained in CymaBay's filings with the
For additional information about CymaBay visit www.cymabay.com.
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