Ardea Biosciences Inc. (RDEA) recently announced additional positive results from the completed first cohort of an ongoing mid-stage, proof-of-concept (POC) study of RDEA594, for the treatment of hyperuricemia (abnormally elevated uric acid levels) and gout. Data from the study were presented at a medical meeting in Philadelphia, Pennsylvania.
Results showed that RDEA594 significantly lowered serum uric acid levels in gout patients and was well tolerated with no serious adverse events and no premature discontinuations. Approximately 90% of the gout patient population consists of patients who excrete less than normal amounts of uric acid and are the primary target for treatment with RDEA594. At the same time, results also revealed that the drug is not more effective than current medication − allopurinol − a cheap generic.
Ardea is aiming to develop RDEA594 as an add-on or alternative for patients who do not benefit from the existing medications for gout. Ardea is evaluating the drug in combination with allopurinol and in combination with Takeda’s (TKPHY.PK) Uloric (febuxostat). A mid-stage study to evaluate the combination of Ardea’s gout candidate with allopurinol against allopurinol alone is ongoing; data from the study is expected by the end of 2009.
Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. Gout is the most common form of inflammatory arthritis in men over 40. The incidence and severity of gout is increasing in the United States (>5,000,000 potential patients). There was a 288% increase in gout-related hospitalizations from 1988 to 2005. Uloric is the only drug to be approved for hyperuricemia in the U.S. in the last four decades. Consequently, we believe that RDEA594, which has been well-tolerated in clinical development so far, can serve the market which has a huge unmet medical need effectively, on approval.
Currently, we are Neutral on Ardea.
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