Seladelpar is an investigational, potent, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist or delpar, in development for PBC treatment. The MAA application includes data from across the seladelpar PBC clinical development program in over 500 people with PBC, including from the pivotal, double blind, placebo-controlled, global Phase 3 RESPONSE study, recently published in the
The application is further supported by data from the Phase 3 ENHANCE study, the long-term open label ASSURE study, Phase 2 studies, pre-clinical studies and includes chemistry, manufacturing, and controls data.
“People living with PBC in
Under the European centralized licensing procedure, the
Seladelpar received Priority Medicines (PRIME) status from the EMA in 2016, as part of its program to enhance support for the development of medicines that target an unmet medical need. Seladelpar has been accepted for review by the
PBC is a rare, chronic inflammatory liver disease that can lead to liver cirrhosis and an increased risk of liver-related mortality. People living with PBC can experience symptoms that significantly impact their quality of life such as itch and fatigue. New treatment options seek to help prevent further disease progression by reducing inflammation and bile acids in the liver and help provide meaningful relief of pruritus.
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, ALT, and GGT, enzymes found primarily in the liver, as well as 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 potential regulatory acceptance of seladelpar, the timelines for regulatory review, the potential for seladelpar to treat PBC and potentially improve biochemical measures, clinical symptoms or outcomes of the disease 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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Source:
2024 GlobeNewswire, Inc., source