This compound is an interesting compound, ALZ801. It’s also pronounced valiltramiprosate. So it’s a very unique small molecule oral compound that actually inhibits the beta amyloid at the oligomer level. So it works upstream and in connection many times with monoclonal antibodies. So it’s a very unique mechanism of action that is oral, safe, well tolerated, and very effective. You know, there was recently published findings, but the results of the APOLLOE4 trial which was a large Phase III trial looking at both mild cognitive impairment and alzheimer’s disease subjects and was pre-stratified for pre-specified for the MCI group as well as the Alzheimer’s group...
This compound is an interesting compound, ALZ801. It’s also pronounced valiltramiprosate. So it’s a very unique small molecule oral compound that actually inhibits the beta amyloid at the oligomer level. So it works upstream and in connection many times with monoclonal antibodies. So it’s a very unique mechanism of action that is oral, safe, well tolerated, and very effective. You know, there was recently published findings, but the results of the APOLLOE4 trial which was a large Phase III trial looking at both mild cognitive impairment and alzheimer’s disease subjects and was pre-stratified for pre-specified for the MCI group as well as the Alzheimer’s group. It was a 78-week double-blind trial testing 265 milligrams BID oral dosing of valiltramiprosate versus placebo in a blinded manner, of course. And the 78-week duration of double-blind, we felt was sufficient in the design to allow placebo to adequately deteriorate. And what we ended up seeing at the end of the 78 weeks, unfortunately, the overall trial was a negative trial and it did not meet the overall goal. But when you look at the pre-specified MCI group and separate that from the Alzheimer’s group on this population, the very interesting and very unique things is you had very positive findings. So the MCI group, the results were actually something that we actually haven’t seen with any of the monoclonals or any other trial in the MCI portion at all. What we saw were, you know, looking at it in the MCI group alone, there was a 52% benefit on the ADASCOG and 102% benefit compared to placebo on the CDR. So that was pretty remarkable. Again, the overall, you know, when you combine it with the Alzheimer’s disease for this homozygote group. So, you know, again, focusing in on the APOE 4-4 individuals, these folks tend to, the disease progresses rather quickly and is also, you know, more aggressive. So we’ll start to see individuals really kind of fall from the MCI to Alzheimer’s very rapidly. And we think that’s one of the reasons why, you know, overall looking at this in the Alzheimer’s population might have been a little bit too late. So again, the overall trial was negative. The MCI group, which was pre-specified, was kind of like a little bit of a home run. But that wasn’t the trial design initially, so hence foreshadowing for the future.
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