So I will start with the introduction of this compound called ecopipam. It is the first in class selective dopamine 1 receptor inhibitor. So far, as I mentioned, we were using D2 inhibitors, so there’s an antagonist, so this one, or modulators, and this one is targeting a different receptor in the basal ganglia, and what we’ve learned in the previous trials, previous phases, is that it seems to work better than placebo...
So I will start with the introduction of this compound called ecopipam. It is the first in class selective dopamine 1 receptor inhibitor. So far, as I mentioned, we were using D2 inhibitors, so there’s an antagonist, so this one, or modulators, and this one is targeting a different receptor in the basal ganglia, and what we’ve learned in the previous trials, previous phases, is that it seems to work better than placebo. In a Phase IIb trial in a pediatric population, it shows that there is at least a 30% improvement in patients on the drug compared to placebo, which was statistically significant. And patients who were in the open-label extension afterwards, they even had an improvement of 40% at 12 months. So this trial that I was presenting at AAN is actually looking at efficacy and safety, tolerability of this drug when it’s given for a longer time. And the way the trial was designed was that patients initially, everybody who was enrolled and was at the baseline visit, was getting the medication, so the first part was called open label, all the patients were exposed to the medication, and many of them had an improvement, but they had to maintain the improvement at week 8 and then week 12, so for a whole month they had to have a meaningful improvement, which is more than 25%, more or equal to 25% of the tic severity that was seen initially at baseline. And at this point, there was a randomization, so we randomized patients into ecopipam arm and placebo, placebo withdrawal, so they were getting less and less medication for a couple of days or weeks, depending on their weight, and then they remained randomized for as long as they had so-called relapse, and relapse was defined as they were losing half of their benefit that they were getting at the randomization. And so then we were looking at how long did it take for patients on ecopipam compared to placebo to relapse. And what we found, which was really exciting, is that patients for 12 weeks of duration of this part of the trial, patients on ecopipam were not really reaching this 50% threshold, so they continued to have some benefit compared to the placebo. And so we looked at what is called a risk reduction, and they had 50% risk, the patient on ecopipam had 50% risk reduction compared to placebo, and this was clinically and statistically significant. And then the secondary outcome measure, secondary endpoint was to look at the whole population of pediatric and adults, and we saw similar trends, similar results, so that was also very reassuring. In terms of the side effect profile, because that’s really important, especially that this is one of the few trials specifically in mostly pediatric patients, we always worry about serious adverse events, and thankfully, there was hardly any serious adverse events. There were some mild side effects, such as patients experienced somnolence, especially initially, some fatigue, or some patients also had insomnia, which, with time, in many, have improved, and there was some anxiety or depression that we saw at this trial, but what is really important is that we did not see weight gain or metabolic side effects, and we did not see these movement-related adverse events that we can see in some other drugs. So there is definitely an unmet need to find medications that will be effective and not have serious side effects. And when we looked at this trial, as I said, the results are very promising, but it has to go through the FDA approval, and this is currently being actually under an FDA commission process, it will take several months, and it’s hard to know when the drug will be available, we hope maybe at the end of 2026, but it could be 2027.
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