ISC 2026 | Results from the FASTEST trial: recombinant Factor VIIa for the treatment of hemorrhagic stroke

The FASTEST trial was designed to see whether or not we could have a hemostatic treatment for intracerebral hemorrhage. The agent we are testing is called recombinant Factor VIIa, which is we make a protein that we find in our own body that helps form blood clots and plug leaks. So the idea is to give that and plug a leak that’s happening in the brain. There’s been several studies that have been before this that suggested that if we could give it early, within two hours, and with people who are not too old and don’t have too big a hemorrhage, that we’d be able to maybe improve outcome. And we know that the agent does slow bleeding, but it has some risks with it as well. So we did the FASTEST trial, which was done globally in a number of countries, including the United States. And we were in what’s called an interim analysis, was our second look at the data, after we had, at that point in time, recruited 424 subjects. And at that point in time, they followed up for six months. And the data safety monitoring committee said, hey, you know, we want you to halt recruitment in this trial at this point in time. And the reason is because the overall there’s futility, but there’s a signal in other groups that we would like you to see about reconfiguring the study to go forward. So what we found with the overall group was that there was no difference in our primary outcome, which is a modified Rankin score of zero to two, three, and four to six. Zero to two is, are you functionally able to take care of yourself on a daily basis? Three is you can walk, but you need some help with daily care. And four to six are very severe, more severe problems with function and disability and also death is six. And with that, there was no difference between the two treatment groups overall. There was not a difference in some of our clinical measures as well, our other clinical measures. But what we did find, as we suspected, is that it did slow bleeding by about three and three-quarters cc’s, or milliliters, Factor VIIa compared to placebo, for intracerebral hemorrhage. And if you combine hemorrhage in the brain and hemorrhage inside the ventricles, it was about five and a half milliliters that was slowed. So we slowed bleeding overall, but we didn’t improve outcome. And there was a 3% increased risk of events, of thromboembolic events that were serious that were more common in the Factor VIIa group compared to placebo. So small increased risk, but it was there. What was interesting, the interesting part of the study is when we began to look at predefined groups that we said we were very interested in. And the two groups that had a very strong signal of potential benefit were people who were treated within 90 minutes, even quicker, and those that had a positive spot sign on a CT angiogram. What a spot sign on a CT angiogram is, is that we give a contrast dye to look at the blood vessels. But if you have a leaky blood vessel in the hemorrhage that’s bleeding still, you’ll see the dye form a little spot that looks even whiter than the hemorrhage itself. And so that, those two groups, were associated with a better outcome that neared statistical significance at 180 days and was significant at 90 days. So the odds ratio at 90 days were 2.7 and 2.5, which are very good odds ratios. But that clinical advantage, benefit, the most important thing is that it was linked to a great decrease in the volume of hemorrhage. So, for example, if you did not have a spot sign on your baseline CT scan, recombinant Factor VIIa did slow bleeding by about two and a half cc’s, which is about half a teaspoon. If you had a spot sign, on the other hand, the difference was 14 cc’s less growth, which is a tablespoon. That’s a big difference. So there was this linking between the better outcomes in these subgroups and less bleeding substantially. So most of the benefit was in these subgroups. And it makes sense in that if you have something whose primary goal is to stop bleeding, you need to identify those people who are most likely to have ongoing bleeding. And so that’s what we found. And what we’re doing now is we’ve now reconfigured this study per our suggestions of our Data Safety Monitoring Committee, to focus just on those two subgroups who had the most clinical benefit and also the associated major decrease in the amount of bleeding.

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