Boston, MA 09/30/2014 (wallstreetpr) – CymaBay Therapeutics Inc (NASDAQ:CBAY) declared that it has finished the enrollment process for its Phase IIb study of arhalofenate in gout patients.
According to an article, the study aims at evaluating the efficiency of arhalofenate in the prevention of flares. The company informed that the safety of the treatment was reviewed by the Data Monitoring Committee earlier in the month. Based on the analysis, it was recommended that the study be continued as previously planned.
About The Study
Arhalofenate is an ongoing treatment for gout that is a chronic and progressive disease that occurs due to an inflammatory reaction to uric acid crystals. The disease is caused from of the depositions of these crystals in soft tissues and joints because of excess sUA or hyperuricemia. It is the most common type inflammatory arthritis that is found in more than 8 million people in the U.S.
CymaBay Therapeutics Inc (NASDAQ:CBAY)’s study is double-blind, randomized, active comparator, and placebo-controlled which seeks to analyze arhalofenate capabilities in terms of prevention of flare and sUA-reduction. It also checks the safety of arhalofenate. The therapy is a once-daily, oral routine that has shown significant reduction in gout flares and sUA during clinical trials. Arhalofenate exhibits a dual action mechanism that demonstrates uricosuric, as well as anti-inflammatory properties.
Study Data
CymaBay Therapeutics Inc (NASDAQ:CBAY) announced that the Phase IIb study has crossed the target enrolment of 225 gout and hyperuricemia patients. The subjects have had three or more than three flares in the last one-year period. The initial endpoint of the trial measures the rate of flare incidence for the arhalofenate (800 mg) arm in comparison to allopurinol (300 mg) after 12 weeks of therapy. In addition to this, as a secondary endpoint of the study, the company measured the serum uric acid (sUA) responder rate for the therapy arms. The sUA responder rate is essentially the percentage of people that demonstrate sUA levels lower than 6mg per liter.
CymaBay seeks to disclose the top-line findings from the study by Q2, 2015.
