Recently, Ardea Biosciences Inc. (RDEA) announced encouraging results on its gout candidate RDEA594 from a mid-stage study (n=208). The 4 week study evaluated the efficacy of Ardea’s gout candidate as a combination therapy with allopurinol (the current standard of care) in patients with elevated uric acid levels in spite of being on a stable dose of allopurinol. RDEA594 focuses on increasing the excretion of uric acid to bring  it to normal levels  in the body.

The study revealed that the reductions in serum uric acid levels and response rates were statistically significant and increased in a dose-related manner for the combination therapy as against allopurinol as a monotherapy.

Preliminary results from the randomized, double-blind, placebo-controlled, study revealed that up to 89% patients treated with the combination of RDEA594 (600 mg) and allopurinol achieved the targeted serum uric acid level of below 6 mg/dL. However, treatment with the current standard of care, for which the bulk of prescriptions for chronic gout are written, is adequate for only 30-40% patients suffering from gout. Moreover, the combination therapy was tolerated well in the study.

Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. This causes deposition of uric acid crystals in and around the connective tissue of the joints and in kidneys, leading to inflammation, formation of disfiguring nodules, intermittent attacks of severe pain and kidney damage. The incidence and severity of gout is increasing in the US.

Ardea will target a highly lucrative gout market if RDEA594 manages to hit the market. On approval, RDEA594 will compete with Savient Pharmaceuticals Inc.’s (SVNT) Krystexxa and Takeda’s Uloric. Apart from Ardea, companies like Regeneron Pharmaceuticals, Inc. (REGN) are also developing treatments for gout.

Currently we are ‘Neutral’ on Ardea, which is supported by the Zacks #3 Rank (‘Hold’ rating) carried by the company in the short-term.

 
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