So we did an analysis that we presented at AD/PD and we showed a 5.6 month time savings with donanemab from their TRAILBLAZER study, the Phase II and then we did an analysis for lecanemab using their Clarity Phase III data and saw a 5.1 month time savings, both of these with 18 months of treatment. We also looked at aducanumab and within the EMERGE study, the results are similar. If you do both studies together, it goes down to about 2.6 months savings or around two and a half. So all of those we had presented at AD/PD and with the new analysis that I presented here at AAIC, we also added two new studies. One of them is souvenaid, it’s the LipidDiDiet study, and that study at 18 months showed over six months of time savings, 6.3 months actually, and that was really impressive because it’s showing as much treatment effect as lecanemab but it’s a nutritional supplement. So, you know, the safety aspects are substantially different. It’s a lot safer treatment to take and there are a lot fewer groups that need to be excluded from that kind of treatment, which is nice.
We also demonstrated that using the time saved approach gives you extra power, and that tends to be really helpful for proof-of-concept studies. So we showed data from AD04 which was a vaccine that was tried in an early study, saw some effects, and you could see an 8.9 month savings with statistical significance. It was a very small study. We don’t know if it’ll replicate or not, but using that methodology allows you to see more in these small studies than you otherwise would be able to.
One other thing on souvenaid, that study actually goes all the way out to 36 months and it looks like there’s increasing benefit, meaning the first 18 months you’re saving 6.3 months. If you continue going out to 36 months, you save even more than that in the next 18 months. So you’re getting over 20 months of time savings with that treatment in 36 months of treatment and, you know, some of those studies are small. There were more dropouts by then. So there’s some caveats around it, but it still looks really promising.
So most of the people on the AUR panel are clinicians and the guidelines are how do we use this in practice? And as the statistician on the committee, my role is to just make sure the numbers we’re looking at are accurate, make sure that all of those considerations in terms of patient population, outcomes… are accurate. But what I realized is many of the things that they were talking about were safety considerations, and they would talk about risk benefit assessment and my thought was, well, we can’t really assess risk benefit if we aren’t saying something about the benefit that’s seen here and that’s not really the purpose of the AUR, because they’re just saying if you want to treat people like or people with this treatment, how do you do it? And to be able to discuss with a patient, should you be taking this treatment or not, they’re looking at these safety concerns and they’re saying, is it worth the safety concerns? And to be able to answer that, they have to know what benefit they’re going to get and so what I showed was just the one single slide that shows that 5.1 month savings with 18 months of treatment and then talked about how do you explain that to a patient? It means you progress 5.1 months less in 18 months than you would otherwise. Any milestones that you would hit should be delayed by five months. It means if you won’t be able to drive at some point, hopefully you’ll have five more months driving. If you have to go into a care facility, it’ll be hopefully five months later and with 18 months of treatment, if that is truly disease-modifying, that benefit should stay with you forever. And we don’t know for sure if it will continue to accumulate beyond the 18 months, if the second 18 months will also give you some benefit, but if it does then it could benefit you even further beyond that and so that’s a possibility with this. So I think if patients and caregivers are having this conversation with clinicians and clinicians are trying to explain what is the benefit that you need to get and you’re willing to take these safety concerns to be able to get that benefit, you have to know what that is and is five months of additional function worth the risk of these ARIA events? And for some people, maybe it is and other people, maybe it’s not.
