Ardea Agrees with FDA on Gout Candidate

Recently, Ardea Biosciences, Inc. (RDEA) announced that it is in agreement with the US Food and Drug Administration (FDA) regarding the key features of the late-stage studies, expected to commence by year-end, of its gout candidate lesinurad (formerly RDEA594). Ardea reached the agreement with the US regulatory body following the end-of-phase II meeting regarding lesinurad, Ardea’s lead pipeline candidate.

Ardea and the US agency are on the same wavelength regarding the size and design of the studies, their main objectives, the total safety database proposed for filing the new drug application, and plans for manufacturing the candidate.

We note that lesinurad has performed well so far in clinical trials. Recently, Ardea initiated a multinational, interventional study to identify gout patients who have failed to attain target serum uric acid (sUA) levels following allopurinol therapy (the most widely prescribed medicine for treating gout).

Moreover, the study will help identify patients to be enrolled for the late-stage study which will evaluate lesinurad as a monotherapy. The study will evaluate patients in whom allopurinol is contraindicated. Furthermore, Ardea also intends to study lesinurad in conjunction with Takeda’s gout therapy Uloric (febuxostat) in another late-stage trial.

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

Our Recommendation

Currently, we have a Neutral stance on Ardea in the long run. The company carries a Zacks #3 Rank (Hold rating) in the short run.