It’s just, in the cohorts A and B, they’re actually getting four and then there’s a three-month separation. In the other cohorts, there is we have the fourth dose separated by a month. So, it’s a slight difference between the two. So, it’s not really three versus four. It’s really six doses over about a six-month period, just exactly how they’re spread out. We will make a final decision on that with the agency looking at all of our data. But I don’t think there will be a material difference between the two. We were just testing them out just to see if there was any difference in how patients would behave or what safety would be like. But right now we feel comfortable doing either. Now on the UX143 timing, we got done here in April essentially.
The timing for the interim, it depends a little bit on when we think the fractures would be hit and timing. Our expectation is coming toward the end of the year, possibly early in the next year. So, it’s around that same timeframe. It’s not really changed. We just want to be clear that we have to there’s a lot of factors that come in and doing the interim. And so, it also is happening in December, let’s say December, January. So, it’s a lot of other things going on. But we’re not really changing that. I think it could begin — it could happen in early January before we would hear. Keep in mind that the actual process may begin for sure. And then it takes time to get through it because they have to clean the data, prepare it, analyze it, DMC meeting and then release it.
But so, our expectation is DMC opportunity for review would be end of the year, early next year. If it’s positive and hits less than P value less than 001, then we would hear about it. If it’s not positive, then it’ll go on to the next one. We set that stringent standard, so it may not mean much to miss because I think it could be a great result, which is not quite 0.01, but that’s the timing. Hopefully that’s clear for you.
Operator: Our next question comes from the line of Dae Gon Ha with Stifel. Your line is open.
Dae Gon Ha: Hey, good afternoon. Thanks for taking our questions and congrats on the progress. I’ll just bundle the questions and ask two straightaway. So, on the GTX-102, when the press release talks about other regulatory meetings in the second half, I mean, you’ve obviously had conversations with the FDA, but what do you think are some of the divergences or differences that they might bring up in terms of endpoints, for example, or even trial design like enrollment and duration? And then second question, just going earlier to the 401 GSD1a, Can you provide a little bit more color on how you’re thinking about presenting the euglycemia throughout the night since that’s such an important aspect for KOL? Thanks so much.
Emil Kakkis: Sure. So, the other [INDISCERNIBLE] meetings is just normal habit with a product of this important to the size that you’re going to talk to the European authorities and you’re going to talk to the Japanese authorities about what we’re doing. The FDA review to is really the dominant view. It will drive the decision making. We’ve had preliminary discussions, so it’s not like we haven’t had any. The design of the study is pretty standard. The expectation is likely to be day 338 or 48 weeks steady. So, I think these are pretty standard choices. I don’t expect there to be much problem with them. And I don’t actually think there’s going to be a lot of differences. If there were some differences on endpoints or we can of course customize the statistics plan for each region, which we have done in other programs when necessary.
But I think the hardwired pieces, randomized trial, 100, 120 patients and that basic design, I think that’s going to be a universal. I don’t think there’s going to be any problem. So, the rest of it is going to be more about statistics and positioning, if anything. We’re comfortable though that what we’re proposing is pretty straightforward. And I don’t really think that will be a problem. But of course, there can be feedback. As I said, the FDA’s position would dominate in our choices for going forward. With regard to the, GSD1a program, during we’ve been presenting the data looking at the fraction of time between the low and the high, right. That’s been mostly what we’ve been doing, Eric, right. And we’ll likely look at the nighttime on the CGM monitor, where the patients are asleep and CGM is monitored.
And we’ll look at those tracings. When we did that during Phase I/II, I was the most impressed with you take kids who were not taking starch at night any longer, and you can watch their glucose, you can see their glucose turn the corner and stabilize. And so, you knew their livers were turning on and releasing glucose. So, we’re going to look for that pattern that they can safely go through the night and that their livers are going to keep them safe. So, we’ll be able to do that even looking at CGM. I wasn’t sure you think there’s anything else, Eric?
Eric Crombez: Yeah. We are maintaining the controlled fasting challenge in the hospital setting. So, we will bring them in, fast them overnight and monitor them in a controlled setting. So that’s further support from the really large amount of data we’ll be getting from the CGM on a daily basis.
Dae Gon Ha: So, am I understanding it correct? It’s going to be an average graph, if you will, across the treated and untreated across the 48 weeks of what the low versus high would be on an every night basis?
Emil Kakkis: Yes. So, for each patient, there’s an interval time where we’re doing intensive monitoring of their glucose levels. During those periods, we’ll take that, create an average for each patient of where they are in their range, right? Set their target. We’re not averaging and then doing the mean of it. We’re taking each patient for their own control range. And then we’ll do the mean of that. And you’ll see a graph, which we’ve had before like a bar chart that shows, where the two groups, how they’re ranging over time between the high and the low. So, we can talk more about that, but there’s a way to present this over time. So, you can kind of see the sense of improving control, decreasing hyperglycemia and maintaining no hypoglycemia, and tightening up over time which is what we’ve been watching in our other patients.
Operator: Our next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Your line is open.
Kristen Kluska: Hi, good afternoon. Thanks for taking my questions. We often get asked about setting expectations for the first interim readouts for setrusumab. Could you please help us frame what are some of the factors that are controllable that we can kind of help to predict in advance? And then some of the items where we’re less sure about it and again, how to help frame these two expectations? Thank you.
