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CymaBay Therapeutics to Present Results From Two Arhalofenate Phase 2 Studies at the American College of Rheumatology (ACR) Annual Meeting, November 6 - 11


CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, today announced that the results from two Phase 2 studies of arhalofenate will be presented at the American College of Rheumatology Annual Meeting, being held November 6-11, in San Francisco, California.

Date/Time: Monday, November 9, 5:15pm - 5:30pm Pacific Time
Oral Presentation: "A Study to Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients"
Session Type: ACR Concurrent Abstract Session
Abstract: 2111
Authors: Alexandra Steinberg1, Harinder Chera1, Yun-Jung Choi1, Robert Martin1, Charles McWherter1, Yunbin Zhang2, Pol Boudes1 on behalf of the Arhalofenate Anti-Flare Therapy Study Group,
1Cymabay Therapeutics, Newark, CA,
2INC Research, Raleigh, NC

This was a double-blind, placebo controlled phase 2b (NCT02063997) study which enrolled 239 subjects with gout, hyperuricemia and a history of flares. Patients were assigned (1:2:2:2:2) to treatments with placebo, arhalofenate 600 or 800 mg, allopurinol 300 mg or allopurinol 300 mg administered with colchicine 0.6 mg. The primary efficacy endpoint , a comparison of flare rates between the arhalofenate 800 mg and allopurinol 300 mg groups, was met with arhalofenate showing a 46% reduction (p = .0056) in flare rate. Additional key outcomes included a 41% lower flare rate for the arhalofenate 800 mg group compared to placebo (p = .049) and reductions in sUA for the arhalofenate 600 and 800 mg groups at 12 weeks vs. placebo that were statistically significant (p = .021 and .0059, respectively). Arhalofenate was well tolerated and appeared safe.

Date/Time: Tuesday, November 10, 9:00am - 11:00am Pacific Time
Poster Presentation: "A Study to Evaluate the Pharmacodynamics, Pharmacokinetics and Safety of Arhalofenate in Combination with Febuxostat When Treating Hyperuricemia Associated with Gout"
Session Type: ACR Poster Session C
Abstract: 2351
Authors: Alexandra Steinberg, Yun-Jung Choi, Robert Martin, Charles McWherter and Pol Boudes, CymaBay Therapeutics, Newark, CA

This was a single-center, open label phase 2 (NCT02252835) study that enrolled two cohorts of gout patients with hyperuricemia (mean sUA of 9.4 and 9.2 mg/dL; n = 16 each). Cohorts were administered arhalofenate 600 or 800 mg as monotherapy, followed by combination with febuxostat (40 and 80 mg), and finally by febuxostat as monotherapy. The combination of febuxostat (Uloric™) and arhalofenate demonstrated a potent serum uric acid (sUA) lowering activity. For the highest dose combination (arhalofenate 800 mg with febuxostat 80 mg), a 63% reduction from baseline in sUA was observed resulting in 100 and 79% of patients achieving a sUA < 5 and < 4 mg/dL, respectively. There was no significant pharmacodynamic interaction between arhalofenate and febuxostat. The combination of arhalofenate and febuxostat was well tolerated and appeared safe.

Posted-In: News FDA Press Releases


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