California based biotechnology company, Ardea Biosciences, Inc. (RDEA) Thursday revealed additional positive results from a recently completed Phase 2a study of RDEA594, a drug indicated in the treatment of hyperuricemia and gout, as well as additional positive results from the second panel of a Phase 1 drug-drug interaction and pharmacodynamic study of RDEA594 in combination with febuxostat.
The combination of RDEA594 and allopurinol reduced serum urate levels an additional 24% compared to allopurinol alone in the second group of a Phase 2a study evaluating the lowering effect, safety and tolerability of combining RDEA594 and allopurinol in gout patients with hyperuricemia.
Adding 200 mg of RDEA594 QD to allopurinol for an additional week produced a 48% reduction in sUA from baseline with all patients responding. Increasing the dose to 400 mg of RDEA594 QD for an additional week resulted in a 54% reduction of sUA from a baseline of 10.2 mg/dL to a mean of 4.6 mg/dL, which represents a 24% reduction in sUA levels from levels achieved on allopurinol alone.
The study revealed the combination of RDEA594 and allopurinol was well tolerated with no significant abnormalities were reported. In the previously reported first cohort of this study, RDEA594 produced significant reductions in sUA levels, was effective in patients with mild to moderate renal impairment, and was well tolerated as a single agent in gout patients with hyperuricemia.
The company indicated that in the second panel of a drug-drug interaction and pharmacodynamic study of RDEA594 with febuxostat in healthy volunteers, 400 mg of RDEA594 QD and 40 mg of febuxostat QD reduced mean sUA levels by 49% and 45%, respectively, when used alone. The combination of RDEA594 with febuxostat resulted in approximately a 70% mean reduction in sUA levels with intraday reductions of over 80%, reaching mean sUA levels of 1.2 mg/dL.
Mark Genovese, professor of medicine and Co-Chief of the Division of Immunology and Rheumatology at Stanford University Medical Center said, "The impressive reduction in serum urate observed when RDEA594 and febuxostat or allopurinol are co-administered indicate that these oral agents with complementary mechanisms may be able to produce reductions in serum urate previously achieved only with intravenous therapy."
RDEA is traded at $14.79 up $0.83 or 5.95%on the Nasdaq.
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