Hello, my name is Charlotte Teunissen, I’m Professor of neurochemistry and I will discuss with you shortly in a pitch what I will present next week and the poster is called, it’s number PO71 and the title is neflamapimod, which significantly lowers GFAP concentrations and correlates with clinical benefits in DLB. And these are results of the RewinD-LB trial. So first about the trial...
Hello, my name is Charlotte Teunissen, I’m Professor of neurochemistry and I will discuss with you shortly in a pitch what I will present next week and the poster is called, it’s number PO71 and the title is neflamapimod, which significantly lowers GFAP concentrations and correlates with clinical benefits in DLB. And these are results of the RewinD-LB trial. So first about the trial. 159 patients with dementia with Lewy bodies were included. They had to have a CDR global score of 0.5 or 1 at baseline. And what was special about this trial is that they, first of all they excluded patients with a high plasma tau level over 27 picograms per milliliter. Because in earlier studies, we had observed that those who have AD co-pathology will have not so favorable reaction to this drug. So we wanted to have pure DLB patients. Hence, we defined that by a plasma tau 181 analysis and next the study was started so divided into placebo and treated, 79 placebo, 80 treated. And the study started but then it appeared that the average blood concentration of the drug was not reached, or not the desired concentration. So there was a switch in batches from batch A to batch B for the remainder of the study. So in this way, there could be a comparison of the different batches. After starting with batch B, the mean plasma concentrations of neflamapimod were reached, so that was positive. And next, there was also a positive effect, especially in the patients treated with batch B. And that’s what was observed. So the change from baseline to week 32 in GFAP, because GFAP was, in earlier studies known to be a responsive biomarker and it was also related to somewhat to cognitive benefits. And in this trial we observed that again so there was a decrease in plasma GFAP levels in patients who were treated with batch B and that was much stronger and significantly stronger because there was nearly an absent change in patients treated with batch A. And next there was a relation with cognitive change so cognitive benefits. So the larger the change in GFAP, the better the cognitive preservation at the end of the trial. So yeah, these results are very promising. So there is a biological effect if you have the right batch of the drug on GFAP and there was also a clinical benefit of this. So that’s really promising and we hope that you will visit our poster.
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