It's been a rough month for development-stage drug company AtheroGenics
AGI-1067, a heart drug, failed in its primary endpoint: showing an improvement versus placebo in its primary outcome of major adverse cardiovascular events. The drug did succeed in a secondary endpoint; however, even this success could be complicated. The danger of relying on secondary endpoints or subgroup analyses of any clinical study is that if the trial data is sliced and diced enough, a positive spin can always be placed on some part of the trial results. Just by statistical chance, a drug candidate like AGI-1067 -- which is being tested in such a diverse patient group as patients with coronary artery disease -- is probably going to be correlated with improved outcomes for some subgroup.
In the case of the ARISE study, AGI-1067 was associated with a 19% reduction in the "secondary hard endpoint" consisting of things like cardiac arrest or heart attack for patients who took the drug. If this secondary endpoint had produced results like this in the past, then AGI-1067 would be on firmer ground going forward. But the previous phase 2 trials of the compound had completely different endpoints, and thus results cannot be compared to see if past studies had produced this outcome. Compounding matters, with a p-value of .028 on this secondary endpoint, there is nearly a 3% chance that this result occurred by chance (assuming patient groups are equal between AGI-1067 and placebo).
AGI-1067 isn't dead in the water yet, but the drug has not produced reproducible meaningful efficacy results in any clinical trial. Probucol, a predecessor antioxidant that AGI-1067 was supposed to improve upon, has produced similar mixed data results across different studies, with some studies even showing the compound to do the opposite of its intended effects.
Shares of AtheroGenics will continue to be volatile in the next couple of months as investors await the probable discontinuation of the company's partnership with AstraZeneca
Keep tabs on big events in tiny technology with a free 30-day trial subscription to David Gardner's Motley Fool Rule Breakers.