![]() And that has a lot to do with the clinical effects that we can see. It just shows that you can learn something from successful trials, but you also learn something from all the other trials because now we know it's not just removing the amyloid, it's how much amyloid you remove, how quickly it's removed, how robustly it's removed. And so that's been incredibly informative because that helps you think about, well what are the next generation of studies going to look like and what are the best approaches to designing that study? So you could sort of put them on a continuum that you have to remove a certain amount of amyloid over a certain period of time to see a clinical effect. So even though it cleared amyloid, it had no clinical effect. And all of those had more clearance than gantenerumab, which was a Roche product that failed its clinical trial. But it's not just removing the amyloid that's sufficient, you have to remove a lot of amyloid and you have to do it at a fairly quick rate in order to get the most robust clinical effect.Īnd so donanemab had a greater clearance than lecanemab, that's the ASI product that was recently approved by the FDA for the accelerated approval, which had more clearance than aducanumab, which was the original Biogen product that got accelerated approval. So that's an incredibly successful trial.Īnd then when you put that in perspective of the other antibodies that have been tested and results have been discussed, what we now kind of know, putting it all together into sort of a bigger picture, is that these antibodies are effective at getting into the brain, whether the trial was successful or not. They didn't progress to the next stage of disease, and it cleared almost all of the amyloid in the brain. ![]() To the patient and to the family what's important is, is my disease gonna slow down? Am I going to be able to maintain my abilities for as long as possible? And how effective is the medicine at getting into the brain and doing what it's supposed to do?Īnd so here we had people who had significant slowing, half the people didn't change at all. And statistics don't mean anything to people who are living with the disease. So the medicine met all of its primary and secondary outcomes.Īnd that's important because if you have to think about not just what's statistically significant, but what is potentially clinically meaningful to a patient. And then we also showed a specific slowing of functional decline and progression to the next stage. Half the people were able to stop the medicine at 1 year, 72% stopped the medicine at 18 months, because they had such complete clearance of the plaque. And that's important because it's a degenerative disease. It showed a significant decline in a global measure, the Clinical Dementia Rating Scale.Īlmost half of the patients actually never changed. ![]() The medication met its primary outcome and had a significant slowing of cognitive and functional decline by a composite score. So we put that all together, the topline sort of discussion. And this is also really helpful, 39%, so again, almost 40%, lower risk of progressing to the next stage. There was 40% less decline in their activities of daily living. ![]() So they no longer had to take the medicines. But here, again, more than half, 52%, at 1 year had cleared, 72% by 18 months had cleared. And that's exciting because right now the best we know about monoclonal antibodies is that once you start, you're pretty much going to continue. ![]()
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