CymaBay Therapeutics Announces A Newly Issued U.S. Patent For The Use Of MBX-8025 As A Treatment For Primary Biliary Cholangitis (PBC)

NEWARK, Calif., Nov. 09, 2016 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for indications with high unmet medical need including rare and orphan diseases, today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 9,486,428. This patent provides coverage to at least 2035 and claims a method for the treatment of PBC with MBX-8025.

"Obtaining patent protection for MBX-8025 for the treatment of PBC is an important step forward in our effort to develop MBX-8025 for PBC, a severe disease for which patients need new therapies," said Harold Van Wart, CymaBay's President and Chief Executive Officer.

About MBX-8025

MBX-8025 is a potent and selective agonist of PPARd, a nuclear receptor important for lipid transport, storage and metabolism in liver and muscle. In a Phase 2 study in subjects with mixed dyslipidemia, MBX-8025 decreased LDL-C, triglycerides and high sensitivity CRP, a biomarker of inflammation. MBX-8025 also decreased alkaline phosphatase and gamma glutamyl transferase, two key markers of cholestasis. In a recently completed Phase 2 study in subjects with primary biliary cholangitis (PBC), MBX-8025 decreased markers of cholestasis and inflammation without appearing to cause pruritus while also lowering LDL-C. CymaBay has also completed a pilot Phase 2 clinical study showing that MBX-8025 lowers LDL-C in patients with homozygous familial hypercholesterolemia (HoFH). The U.S. Food and Drug Administration (FDA) has granted CymaBay orphan drug designation for MBX-8025 as a treatment for HoFH and Fredrickson types I and V hyperlipoproteinemia.

About PBC

Primary biliary cholangitis (PBC), formerly known as primary biliary cholestasis, 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.

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