SOURCE: CymaBay Therapeutics

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September 29, 2014 08:00 ET

CymaBay Completes Enrollment in its Phase 2b Study of Arhalofenate in Patients with Gout

Top-Line Data Expected in Second Quarter of 2015

NEWARK, CA--(Marketwired - September 29, 2014) - CymaBay Therapeutics, Inc. (NASDAQ: CBAY) today announced that it has completed enrollment in its ongoing Phase 2b clinical trial of arhalofenate in patients with gout. The primary objective of the study is to evaluate the efficacy of arhalofenate for the prevention of flares. An independent Data Monitoring Committee reviewed interim safety data earlier this month and recommended the study continue as planned. CymaBay expects to announce top-line results from the Phase 2b study in the second quarter of 2015.

Arhalofenate is a once-daily, oral therapy under development for the treatment of gout that has demonstrated the ability to reduce gout flares and reduce serum uric acid (sUA) in clinical studies completed to date. Arhalofenate has a dual mechanism of action with both anti-inflammatory and uricosuric properties.

Key Highlights:

  • Gout is a chronic, progressive disease caused by an inflammatory response to uric acid crystals deposited in joints and soft tissues as a result of excess sUA or hyperuricemia
  • With more than 8 million people in the U.S. affected, gout is the most common form of inflammatory arthritis (NHANES 2007-2008 Study)
  • CymaBay's ongoing Phase 2b study is a randomized, double-blind, active comparator- and placebo-controlled study designed to evaluate the safety, flare prevention and sUA-lowering activity of arhalofenate. (http://clinicaltrials.gov/ct2/show/NCT02063997)
  • The Phase 2b study has surpassed the enrollment target of 225 patients with gout, hyperuricemia and a history of 3 or more flares in the last 12 months. The primary endpoint of the study is the flare incidence rate for the arhalofenate (800 mg) arm vs. allopurinol (300 mg) following twelve weeks of treatment. A key secondary endpoint is the sUA responder rate (the percentage of patients that achieve sUA levels below 6 mg/dL) for the treatment arms.

About CymaBay

CymaBay Therapeutics is a clinical-stage biopharmaceutical company developing therapies addressing unmet medical needs. Arhalofenate, the company's lead product candidate, has shown two therapeutic actions in a single drug in Phase 2a studies. In gout patients, arhalofenate is intended to prevent painful attacks in joints while at the same time promoting excretion of sUA by the kidney, thereby addressing both the signs and symptoms of gout and the hyperuricemia that is the root cause of the disease. The company has two other product candidates - MBX-8025 and MBX-2982. MBX-8025 is a potent, selective, orally active PPAR-δ agonist. A Phase 2 study of MBX-8025 in patients with mixed dyslipidemia has established that it has an anti-atherogenic lipid profile that may be useful in the treatment of a wide variety of indications currently under evaluation. MBX-2982 is a GPR-119 agonist that lowers glucose in patients with type 2 diabetes.

This press release contains "forward-looking" statements, including, without limitation, statements related to development plans, the timing of planned clinical trials and result. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "planned," "will," "may," "expect," and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on CymaBay's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, the availability of resources to develop CymaBay's product candidates, CymaBay's need for additional capital in the future to sufficiently fund CymaBay's operations and research, the uncertain timing of completion of and the success of clinical trials, market competition, as well as other risks detailed from time to time in CymaBay's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2014. CymaBay does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

For additional information about CymaBay visit www.cymabay.com.

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