This particular trial unfortunately did fail, but in looking at the results, there’s a lot to be very hopeful for, right? In looking at this homozygote population, which, you know, really is this true unmet need that I’d like to circle back to on a little bit, but these homozygote patients and looking at this and seeing the results that we saw with in the MCI population, it’s just really important that obviously that we can replicate that, right? So, you know, the foreshadowing is really the beginning plans are underway to repeat the APOE4/4 Phase III trial, but just in MCI patients...
This particular trial unfortunately did fail, but in looking at the results, there’s a lot to be very hopeful for, right? In looking at this homozygote population, which, you know, really is this true unmet need that I’d like to circle back to on a little bit, but these homozygote patients and looking at this and seeing the results that we saw with in the MCI population, it’s just really important that obviously that we can replicate that, right? So, you know, the foreshadowing is really the beginning plans are underway to repeat the APOE4/4 Phase III trial, but just in MCI patients. Stick with homozygotes 4/4 and N of about 500 patients. Otherwise, same study design, 78 weeks, double-blind, and really let’s give it a go. Now that we know APOE 4/4 has progressed very rapidly, and we really need to intercede much earlier than we did. So I think that’s a sweet spot with this particular agent. I’d like to circle back a little bit on the unmet need for homozygotes and why valiltramiprosate is really important. Right now, we know that a lot of regulatory authorities, as you’re aware, they will not even allow lecanemab and donanemab, for example, even though it’s commercially available to be prescribed in certain countries in certain regions if, in fact, you’re APOE4/4 positive and you’re considered a homozygote. So they will not do it due to increased safety concerns. And in regions like the U.S. where there are no restrictions on homozygote individuals, what we’re seeing is about 80 to 90% of the clinical providers are reluctant and hesitant to actually prescribe monoclonal antibodies commercially without knowing their genotype status due to the increased risk and increased burden of ARIA-E and ARIA-H as a result with those treatments. So from my viewpoint of doing this for over three decades, I just think that there’s a very strong unmet need for homozygotes, APOE4/4. It’s really a different course of action, and we’re really starting to kind of dip our toes into what we call precision medicine for one of the first times ever. So something like this, that even though the general population, this may only account for 2 to 3% of the population. But if you look at Alzheimer’s disease from a statistical standpoint, about 15 to 17% of those individuals that are afflicted with Alzheimer’s disease are actually homozygote APOE4/4. So the risk and the burden level is significantly greater if, in fact, you have it. And it’s a very large chunk of individuals who now we’re seeing regulatory authorities and clinicians are a little hesitant to give them monoclonal antibody treatment, which, you know, thank goodness we finally have something approved and we’ve cracked open that door. But now we just need to do a little bit more and start to kind of hone in on what really matters and some of that is going to be some of these special cases like this APOE4/4 homozygotes. It’s definitely an unmet need that we really need to look at.
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