Recently, Ardea Biosciences Inc. (RDEA) announced encouraging positive results from studies on RDEA594, which focuses on increasing the excretion of uric acid to bring the levels of uric acid in the body to normal. RDEA594 is Ardea’s lead candidate for treating hyperuricemia (serum uric acid greater than or equal to 8 mg/dL) and gout. The new data were presented at the Annual European Congress of Rheumatology, held in Rome, Italy.
Data presented included updated results from a mid-stage monotherapy study of the candidate. The 4 week trial (n=123) evaluated the safety and urate-lowering effects of 200 mg, 400 mg and 600 mg of RDEA594. The study revealed that the levels of uric acid in the blood returned to normal for 60% of patients at the highest dose tested (600 mg). The response rates on placebo, 200 mg and 400 mg RDEA594 were 0%, 13% and 42%, respectively.
Furthermore, data from an early stage study revealed a 100% response rate when RDEA594 was administered in combination with allopurinol (the current standard of care). Ardea further revealed that the results from multiple studies did not indicate diminished efficacy of RDEA594 in patients suffering from mild-to-moderate renal impairment.
The overall safety results from five studies hinted that RDEA594 was well tolerated either alone or in combination with allopurinol or Takeda’s Uloric (febuxostat). No serious adverse events or side effects were reported from the five studies.
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 United States.
The market has a huge unmet need with Uloric, approved in February 2009, being the only new drug to be approved in the United States for the treatment of gout in the last 40 years. Apart from Ardea, companies like Savient Pharmaceuticals Inc. (SVNT), Regeneron Pharmaceuticals Inc. (REGN) and Novartis (NVS) are also developing treatments for gout.
Currently, we have a Neutral recommendation on Ardea Biosciences.
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