Shares of Resverlogix plunged 39 percent yesterday afternoon after the developer conceded that its cholesterol drug RVX-208 had failed to hit a primary endpoint and raised troubling safety issues in a mid-stage study. The developer was also the victim of some very bad timing, releasing its results shortly after Merck's ($MRK) cholesterol therapy-anacetrapib wowed the audience at the annual American Heart Association meeting.
Resverlogix tried to win over the crowd with data demonstrating that the therapy boosted levels of the apolipoprotein A-1, which is linked to good cholesterol. But the drug failed to hit its mark on statistical significance. And analysts quickly began to fret over signs of elevated liver enzymes in some patients taking the drug--a classic red flag in the development world. None of the patients in the placebo arm had elevated levels of liver enzymes while investigators recorded spikes in the enzyme levels of eight people in the 200-mg drug arm and seven patients in the 300-mg arm. There was no evidence, however, of liver damage.
On the plus side, researchers reported that the highest dose did deliver a statistically significant 8.3 percent jump in 'good' HDL levels. But coming right on the heels of anacetrapib's data, reflecting a 138 percent leap in HDL levels after 24 weeks of dosing, Resverlogix's program suffered from some quick comparisons.
Anthony DeMaria, editor in chief of the Journal of the American College of Cardiology, told Bloomberg: "If you asked me do I think this company should go forth with a definitive phase three trial, I would say it's 50/50 at best."
- see the Resverlogix release
- read the story from Bloomberg
- and here's the Dow Jones piece
- check out the Reuters story