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April 1, 2010
Ardea's Gout Drug Progresses
Posted by Derek
Ardea's serendipitous gout drug RDEA594, which I wrote about here last year, is still alive. Phase IIb results had the compound meeting its endpoints (although not at the lowest dose), so on it goes to Phase III. Since we've been talking all week around here about how Phase III is a different world, it's worth noticing that the primary endpoint is still a biomarker (reduction of serum urate levels), not a real clinical outcome. But in the case of gout, that association is probably strong enough to be optimistic. Good luck to 'em.
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1. Pharma Conduct Guy on April 1, 2010 10:10 AM writes...
Although I agree that more drugs need to be evaluated in the context of a clinically meaningful outcome, which can be hard to measure objectively sometimes, in this case, reduction of serum urate levels is a good goal, since, as you say "that association is probably strong enough to be optimistic". The mechanistic basis for gout is fairly well-understood (uric acid buildup and crystallization in the joints or other tissues). Having an easily measured, objective pharmacodynamic marker is great.
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