Profile: Cymabay Therapeutics Inc (CBAY.O)
CymaBay Therapeutics, Inc., incorporated on October 5, 1988, is a clinical-stage biopharmaceutical company. The Company is focused on developing therapies to treat metabolic diseases, including serious rare and orphan diseases. Its pipeline includes three unpartnered clinical stage product candidates and a number of preclinical programs. Its product candidates include Arhalofenate, MBX-8025 and MBX-2982. Arhalofenate is used to treat gout. MBX-8025 is a selective agonist for the peroxisome proliferator-activated receptor delta (PPARd). MBX-2982 is an oral, G-protein coupled receptor (GPR119) agonist being evaluated as a therapeutic agent for patients with Type 2 diabetes (T2DM), with a dual mechanism, including direct effects and indirect effects mediated by gastrointestinal hormones known as incretins on glucose-dependent insulin secretion, as well as potentially beneficial effects on islet health.
Arhalofenate is an anti-inflammatory uricosuric drug that reduces the risk of gout flares while also lowering sUA (serum uric acid). The Company's Arhalofenate has been studied in over five Phase II clinical trials in patients with gout. It has evaluated the safety and efficacy of arhalofenate in doses ranging from 400-800 milligrams monotherapy and in combination with the approved xanthine oxidase (XO) inhibitors, allopurinol and febuxostat. Arhalofenate has been studied in a total of over 20 clinical studies with over 1,100 subjects in healthy volunteer, type 2 diabetic and gout populations.
MBX-8025 is used to treat a range of disorders of lipid metabolism and certain diseases of the liver. MBX-8025 has potential therapeutic application for disorders linked to deficits in lipid storage, handling and utilization, many of which result in metabolic disorders. The Company has completed over five Phase I clinical studies and a Phase II clinical study for MBX-8025. MBX-8025 treatment increased peripheral oxidation of fatty acids leading to reduced levels of triglycerides (TGs) and low density lipoprotein (LDL)-C, while raising high density lipoprotein (HDL)-C. MBX-8025 also inhibited fat mass accumulation, resulting in attenuation of body weight gain in rodent models of obesity. MBX-8025 is also used for treatment of a range of rare diseases associated with disorders of lipid metabolism, such as Non-Alcoholic Fatty Liver Disease (NAFLD)/Nonalcoholic Steatohepatitis (NASH), homozygous familial hypercholesterolemia (HoFH) and severe hypertriglyceridemia (SHTG) syndromes, and disorders of liver function, such as primary biliary cholangitis (PBC). The Company initiated a Phase II study of MBX-8025 in patients with HoFH. A third Phase II clinical trial is ongoing in patients with PBC. It is in Phase II clinical trials in patients with SHTG.
MBX-2982 has been shown to increase glucose-dependent insulin secretion in both in vitro and in animal models. MBX-2982 also increases incretin hormone levels in animals, which contributes to its glucose lowering effects. Nonclinical studies show that MBX-2982 has desirable effects on blood glucose levels, and this effect is additive to the effect of the dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin. The Company has completed over four Phase I clinical studies and a Phase II clinical study for MBX-2982. A proof-of-concept study has been designed to determine the effects of MBX-2982 on fasting and post-challenge blood glucose in patients with T2DM either as dual therapy in combination with either metformin or sitagliptin, or as triple therapy in combination with metformin and sitagliptin.
Cymabay Therapeutics Inc
7575 Gateway Blvd Ste 110
NEWARK CA 94560-1194