When asked why there was a lack of dose dependency between 30 and 50mg by Soumit Roy in the Q2 CC, CM revealed that the 50mg cohort ended up having a similar 30mg target due to titration issues. So effectively, the p2b/3 trial only tested 30mg vs placebo. It raises whether regulators require a clear dose dependency confirmation trial before granting an MAA/NDA approval.
Do we know whether both 30mg and placebo patients or all patients were supposed to titrate to 50mg or only the placebo cohort? That might catch some dose dependency with the new titration procedure.
Soumit Roy
Good morning everyone and thank you for taking the question. And also congrats on executing on multiple fronts. On the AAIC data, Alzheimer disease, could you give us a little color, make us understand on the dose dependency or a clear lack of dose dependency between 30 milligrams and 50 milligram? There was ADAS Cog was working a little better for the 50 milligram versus CDR-SB for the 30 milligram. And the discontinuation rate are, so what percent of the 50 milligram did you see had to scale back to 30 milligram because of adverse events in the open label extension?
Christopher Missling
So let me address the first question first. So the two arms are those groups, and we use the expression for that reason. When you read our description in the presentation, we talk about the dose groups, 30 milligram dose group or 50 milligram group. So since we allow titration to the best tolerated dose for those two arms as well as placebo, by the way, we basically realized that the end of the day, the target dose for most patients was relatively close to each other in those two arms. So while in the 50 milligram group, there were some with 50 milligram, there were also some with 30.
So it was a bit higher than the 30 milligram group, but not by much. So they're pretty much close, and that's why I also prespecified the two arms together against placebo in a predefined analysis. So that was the background. So we have seen prior to that a dose response curve in our Phase 2A. So there's no doubt about the dose response is confirmed. But what we now notice is that in this trial where we and that's coming to the second part of the question, where we noticed where we force patients to uptake trait to the target dose 50 very quickly within two weeks and then to three weeks, we noticed that didn't -- was very well received.
Some patients had some dizziness, and they wouldn't feel comfortable about it. So because they're not impaired patients, they're early Alzheimer, they felt saying maybe we have COVID. I don't want to continue this. It was during the time of COVID, of course, as well. So that's why we had some dropouts at the higher dose more than in the lower dose group.
So what we now realized when we did the open label study where we allowed a more, I would say, lenient and less stringent way of up titration in also allowing patients to take the drug at night time instead of in the morning, which we basically force patients to take during the trial early in the morning. So we noticed that there was much higher tolerance for either dose 30 or 50 as long as they were allowed to get used the drug for a longer period of time.
And we noticed that also in the Compassionate Use program with this extremely higher tolerance with allowing patients to titrate to 50 or 30 as long as they have enough time to do that and then taking also night time dosing. So we don't see the adverse events, we have seen in this trial because we basically forced them to titrate so quickly up to the target dose. And we also have to point out that it's actually a clearly manifestation of a manageable and addressable adverse event. It's not like, when you look at brain bleeding or brain swelling from the antibodies, which we don't have, that no matter how you take the drug, you always will have 30 or more percentage of patients with that very dangerous side effects of a drug of an antibody, which we don't have.
But in our case, the adverse event of dizziness is a manageable one because it just depended on the titration schedule, and that can be flexible, changed. And that's what we now will, of course, do in the future. So that's the answer to your question. And also, needless to say that we are also acknowledging that, and we've heard that from physicians that the dizziness sign again, not all patients had that. We also have to put this in perspective, that it's a sign that shows penetration in the brain and shows that some thing's happening in the brain.
Also, one last point I'd like to make that this dizziness lasted really relatively short for those patient who had it was sometimes between seven to 11 days in the average. So it's a very -- and a mild form of dizziness. So it's a very easy to address situation, but it shows up in this trial because again, we forced patients to go to these high doses very quickly, and we learned the lesson that we can avoid that.
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