Rick Hawkins: Duke, why don’t you answer that question? Thanks. Appreciate the question, Catherine.
Duke Pitukcheewanont: Yes, thank you, Catherine. That’s a very good question. Our trial is very, kind of unique, right? As you know, when you look at most of Phase III trials, especially long-acting [indiscernible] or Pfizer, majority of those subject that enrolled in a trial have male predominance, right? In our study, it’s pretty much that, male a little bit more than female, but it’s not that huge difference, which is very, very interesting. I think when we go back to the first global Phase III trial, you can see that the number of countries going to increase, the number of sites going to increase because the timeline we want to enroll, we have a goal that we want to complete enrollment within 15 months to 18 months, which is, again, this goal is actually a little bit better than the goal that those previous Phase III trials have been running.
Part of it is that, that’s dealing COVID and now we don’t have COVID and not to mention that we do not expect a lot of competitor to run the Phase III trial, right? And in regards to the oral, I think that to enroll these subjects, I heard loud and clear when they start the Phase II trial to increase enrollment and autonomy manner, we realized that a lot of subjects really interested to participate in these oral LUM-201 trials. Again, I don’t think that we expect any issue to get the patient enrolled, especially most of them would like to be able — to be on this drug and especially during the clinical trial, because it would take years for us to really get the drug approved. I hope that answers all the questions you have.
Catherine Novack: Yes, that’s very helpful. And actually just one more on the end-of-Phase II meeting. We’ve heard over and over from KOLs that growth beyond 12 months is really the most important aspect to them. Are these data going to be a part of your discussion with FDA? And how important is that to the Phase II trial design?
Rick Hawkins: Boy, that is a very good question, Catherine, and I’m going to ask John to answer it.
John McKew: Yes. Thank you, Catherine. So I think the data that we’ve shown about the small subset of kids that we have at 24 months on growth has been very telling. The restoration of normal growth, normal pulsatility, normal IGF-1 levels, and then more natural growth that results from that has led to very consistent and durable growth comparing year two to year one, right? We lose only a small, tiny bit, 6% of our AHV compared to a much larger drop off that you see with daily injectable growth hormone. So that is a really important piece of data that we certainly will chat with the FDA about. We do anticipate much, as Rick said earlier, a standard Phase III trial design of 12 months, but because we have a number of subjects already that have gone past that 12-month time frame, we’re moving subjects from our 24-month long OraGrowtH210 study into a long-term safety extension.
We will have quite a lot of longer-term data by the time we get to Phase III and get to an NDA. So I think that data will be very helpful in addition to what we see in the Phase III 12-month study that Rick described. So it is very important and it will be a very nice package of durable data that we can bring.
Catherine Novack: Great, that’s very helpful. Thanks a lot, guys.
Operator: Thank you. And I’m showing no further questions in queue at this time. And ladies and gentlemen, this concludes the Lumos Pharma Fourth Quarter 2023 Earnings Call. Thank you and have a good day.
