OHM, regarding potential Alzheimer’s pilot study
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Posted On: 05/23/2024 2:24:25 AM
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OHM, regarding potential Alzheimer’s pilot study in patients, do you have any thoughts on how such a study may be set up ?
First step would not be a study with humans. FDA is going to need to see a pre-clinical study. Before you get to do a study in humans you need to show safety (which we should have locked down) and potential for efficacy in that indication. So first study should be in a humanized mouse model . I would think the study from start to finish might be 3 to 4 months.
When we go on to the phase 2 study probably a phase 2a first that will look primarily at safety and secondarily at efficacy with a dose escalation. Followed up by a phase 2b that will look more closely at efficacy. They'll be looking at biomarkers like tau and amyloid - beta, there are newer biomarkers but I don't think they're acceptable to the FDA yet. Being leronlimab we'll certainly be looking at chemokines especially inflammatory ones to help explain the reasoning behind the efficacy. Alongside this will be mental acuity tests to see if there's improvement in cognition.
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