So going forward, as I mentioned, what we plan to do or are trying to get funding to do is first to do a Phase Ib study where we treat healthy but elderly subjects for 28 days with CMS121. And we will follow; we’re planning on using several different doses on either side of the dose that we tested in the original Phase I trial and look at obviously safety and tolerability. But we also plan in this case to look at target engagement...
So going forward, as I mentioned, what we plan to do or are trying to get funding to do is first to do a Phase Ib study where we treat healthy but elderly subjects for 28 days with CMS121. And we will follow; we’re planning on using several different doses on either side of the dose that we tested in the original Phase I trial and look at obviously safety and tolerability. But we also plan in this case to look at target engagement. And we already know that CMS in mice, at least CMS121, can significantly decrease the levels of fatty acids in the blood. So we’re going to use that as one indicator of target engagement. We’re also going to look at markers of this ferroptosis pathway, such as serum ferritin, as well as a marker of oxidative stress in the urine, hydroxyguanosine, and several markers, also high-sensitivity CRP, as we know, CMS121 also reduces markers of inflammation. And in addition, a small portion of subjects we’re going to get CSF from, so to look at the levels of CMS121 in the CSF, which we were told we need to do. So if that goes well, then we plan to do a Phase IIa study where we will not only look at longer-term safety and tolerability, but we will also look at effects on cognitive function. And we have a variety of different cognitive tests that we have planned. And we will also, again, look at markers of target engagement, as well as other plasma markers of efficacy. And this trial will be done in MCI and early AD subjects. And we’re just going to use a single dose, so that we split 75 subjects on a single dose of CMS121 based on the Phase Ib study, and then the other 75 on placebo. And it would be for 48 weeks. As far as I could tell, particularly from attending this CTAD meeting, that there don’t seem to be any other trials or people who are taking this approach of focusing on this ferroptosis pathway as a target for treating Alzheimer’s disease. And since we believe and our data indicates that this may play an important role in disease development and progression, I think our approach has a really strong potential to contribute to treating patients with AD as well as potentially other forms of dementia.
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