About the Company
CymaBay Therapeutics is a clinical-stage biopharmaceutical company located in the San Francisco Bay Area focused on developing therapies to treat metabolic diseases with high unmet medical need or serious rare and orphan diseases. We are committed to developing breakthrough medicines that improve the lives of patients and their families. CymaBay was seeded with the assets from an earlier metabolic disease company in which more than $120M was invested to produce a robust pipeline.
Arhalofenate is a novel oral small molecule being developed to treat the approximately 1 million gout patients that flare three or more times per year. Gout flares are painful inflammatory episodes caused by crystals of monosodium urate (MSU) that result from excess serum uric acid (sUA). In three Phase 2 studies in gout patients arhalofenate was shown to reduce the incidence and duration of flares while simultaneously lowering sUA. If confirmed in additional clinical studies, arhalofenate’s dual acting profile would be unique since all other urate lowering therapies paradoxically increase flares as they lower sUA over the first 6 to 12 months of treatment. Increased flares lead many patients to stop or avoid treatment leading to progression of disease with pain and suffering, erosion of joint structure and functionality, lost time from work, and increased healthcare costs.
MBX-8025 has potential therapeutic application for disorders linked to deficits in lipid storage, handling and utilization and for certain diseases affecting liver function. The pharmacological action of MBX-8025 has been established in a Phase 2 clinical trial in patients with mixed dyslipidemia, which is characterized by elevated levels of low density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) and below normal levels of high density lipoprotein cholesterol (HDL-C). In this trial, MBX-8025 demonstrated favorable effects on LDL-C, HDL-C, TGs and markers of liver health. However, we believe that its greatest benefit to patients and the best path for regulatory approval is likely to be in an orphan or other high unmet need indication. We have identified a range of indications linked to both lipid and hepatic disorders that may be applicable for treatment with MBX-8025, including HoFH (a rare genetic disorder characterized by extremely high levels of LDL-C), SHTG (a disorder characterized by extremely high levels of triglycerides) and PBC (an orphan autoimmune disease of the liver characterized by portal inflammation and destruction of intrahepatic bile ducts). We are currently exploring the feasibility and potential for use of MBX-8025 in HoFH and other orphan diseases.
MBX-2982 is a potential first-in-class treatment for type 2 diabetes that targets G protein-coupled receptor 119 (GPR119), a receptor that interacts with bioactive lipids and results in glucose-dependent insulin secretion.MBX-2982 is a potent GPR119 agonist that has completed four Phase 1 trials and one Phase 2 trial, the latter study in patients with type 2 diabetes. In all studies to date, MBX-2982 was rapidly absorbed, lowered glucose excursions, and was well-tolerated with no serious adverse events.
The Company has considerable experience in drug development, including in recent years having conducted over 20 clinical studies. Our strategy is to advance our product candidates in development to create significant value and, where appropriate, to seek strategic partnerships with organizations that can bring additional expertise to complete the registration and commercialize our products candidates.
To execute our strategy, we have assembled a management team with deep experience in developing promising drugs and technologies, including former executives at Syntex, Roche, Pfizer, Sugen and Amicus
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
– 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...
NEWARK, Calif., Sept. 18, 2017 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need, today announced that management will provide a corporate...
CymaBay Therapeutics Granted EMA Orphan Drug Designation for Seladelpar for the Treatment of Primary Biliary Cholangitis
NEWARK, Calif., Sept. 11, 2017 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need today announced that the European Medicines Agency’s (EMA) Committee...
CymaBay Therapeutics Announces the Publication of the Seladelpar Proof-of-Concept Study for Primary Biliary Cholangitis in Lancet Gastroenterology and Hepatology
NEWARK, Calif., Aug. 15, 2017 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that the proof-of-concept study of seladelpar, a...