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inhibit multiple forms of an inflammatory enzyme called sPLA2. There is no FDA approved drug that works to block this target, although competitors like GlaxoSmithKline, Via Pharmaceuticals, and Eisai Pharmaceuticals are all pursuing some variation on the theme.
By shutting down the enzyme, Anthera hopes it will prevent plaque from forming in blood vessels, and make it more stable there, Truex says.
Anthera, which got a license to the compound from Lilly and Shionogi, went on to run mid-stage clinical trials. It tested its drug in more than 1,000 patients, which gave it enough evidence to entice IPO investors. The extra cash was immediately put to work in the next couple months as Anthera started enrolling patients in the pivotal trial called Vista-16, which it hopes will be good enough to convince the FDA to clear the drug for sale.
The study will randomly assign as many as 6,500 patients with a heart attack (acute coronary syndrome) to get either the Anthera drug or a placebo. These are very sick patients, taking lots of heart medications already, and about one out of every 12 (8.5 percent) is expected to have another serious coronary event, Truex says. About 85 percent of the coronary events are thought to occur in the first 16 weeks, when inflammation is running rampant, so Anthera has designed its study around this short-term (and therefore, stock-market-friendly) time frame.
Anthera designed the study so the moment there are 385 major coronary events in the study (heart attacks, strokes, deaths), then its statisticians will rip off the study blind and see whether the patients on the Anthera drug suffered those outcomes at a lower rate. To declare victory, Anthera needs to see an 18 percent improvement in relative risk compared with the placebo. That might sound great, but in absolute terms, it’s pretty modest. If Anthera’s drug is that good, then about 6.9 percent or 7 percent of patients on it (about one out of 18 instead of one out of 12) will still suffer a major coronary event.
One of Anthera’s main tasks is to generate enthusiasm among doctors and patients for its trial. Because it needs to enroll an estimated 5,000 to 6,500 patients to get the required … Next Page »
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