NP - 07:32 / 09:03 - So that is the first major positive result for us. A very important secondary endpoint is called N.E.W.S. 2, which is a upgraded version of N.E.W.S. stands for National Early Warning Score. N.E.W.S. 2 assesses the degree of illness that points out to any need for critical care interventions.
Very very crucial parameter. So again, this indicates this indicator is to determine the degree of illness of patients, whether the patient will be needing critical care intervention by assessing the following parameters: breathing, oxygen saturation, body temperature, blood pressure, and heart rate.
In regards to these very crucial parameters, we have seen good improvements in leronlimab arm compared to placebo arm in all evaluated days. Which is day three, day seven, and day fourteen. We are so delighted with these results.
3rd result of another secondary endpoint is in regards to patients who needed oxygen use and mechanical ventilators. Leronlimab arm beats the placebo arm.
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On SAEs as endpoints:
Dr. Jay Lalezari - 10:17 / 13:10 -
I was surprised last week by the mixed results that the — what appeared to be a clinically significant reduction in SAEs engendered. These are the the critical endpoints. They're not endpoints that we're used to seeing, because we're not used to seeing a reduction of SAEs in clinical studies. I've been the P.I. of about 300 studies and I have never seen that before, but SAEs are medically significant events, like deaths and intubation.
And these are the, I think, the very events that we would want to see reduced, and what I think is surprising. Is the — what appears to be a very clinically significant reduction in such an early mild-to-moderate population.
I would also comment that what Nader just said about the significant results at day three — as early as day three — that that is very compatible with what we saw during the emergency IND program that first encouraged us to believe the drug was working, where we saw very rapid reductions in IL-6 and increases in CD-8 that started at day three. So, I'm, I think the early results were seeing in this study are compatible with what we've seen in a more severe population. If, if the result was only significant out of day fourteen, I'd be much more suspicious of it, but it is compatible with what we've seen in other patients.
I think what is surprising about what we're getting from CD-10 is that, when we thought the drug was working in severe patients, we didn't think it was going to work during the early vyrologic phase or even necessarily during the early immunologic, the middle immunologic phase. We thought it was really quite encouraging during the hyper information, but the CD-10 study, and we thought that when there was a compassionate use program that the drug would perhaps be indicated for patients who needed oxygen supplemental therapy, but the CD-10 population are patients who are even earlier.
These are folks with mild and moderate — almost who don't require oxygen. And so what the CD-10 study is showing, I think, is that the Leronlimab is going to be broadly effective, not only in the severe and critical, but also in patients who don't even yet need oxygen therapy. And the SAE is — while not a primary endpoint— I think is indicative of that kind of activity. So all of this is pointing, I think, to the the need to quickly take a look at CD-12 and see where we are. Back to you, Nader..
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Then they went on to BLA.
They mentioned earlier in the call that Regenoron just announced that they will be using the # of SAE events as the primary endpoint in their study. Cytodyn didn't use them as the primary. Maybe they should have. Last week they announced SAEs in the LL arms was 64% less than in placebo.
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