Tom McCourt: I mean you can imagine, I mean, having a best-in-class product like this or potentially best-in-class product business, and we are certainly getting a fair bit of inbound interest but obviously, it’s something we’re going to certainly take advantage of as we move forward.
Operator: Your next question comes from the line of Mohit Bansal from Wells Fargo. Your line is open.
Mohit Bansal : Great. Thanks for taking my question. I have two. So, one is like how much information about the secondary end point that you just mentioned, we could expect to see with the top line release in March. That’s the first question. And the second one is, you do have a differentiated leaning mechanism from the parental support. Could you talk a little bit more about that? And could it impact placebo as well as we look forward to the data. Thank you.
Mike Shetzline: Yes, sure. So, as I mentioned, I mean, I can give you the key secondaries are described as I put them forward in the prior question. I mean, the main one is the days of the — at least one day of parental support, you may recall that’s kind of a standard endpoint. It’s been around since the Gattex phase because Gattex use a responder definition and the responder was a 20% reduction. That translated roughly to like one day out of the week and stuff like that. But that’s sort of been one that’s been compared across agents in the class. And then the other two, we’re really just trying to get granular on the subpopulations between stoma and CIC. The stoma is at 24 weeks, as we mentioned, because oftentimes the stoma populations have a higher parental support volume need they tend to respond more quickly.
That’s why the 24 week is also at that point for that reason. The third one is the CIC specific subpopulation, but that’s a parental support volume reduction at week 48 because they often take longer to respond. And then finally, antroautonomy, which is the complete lifelong parenteral support, which we think is a value to patients. And then we’ll certainly share the data in March with the top-line results. And the second question, you talked about the weaning algorithm. The weaning the aspect of weaning — obviously, weaning is a part of the study, right? But the aspect of the difference between Stoma and CIC has been around since the Gattex days and really became clear sort of in the post-marketing approach to Gattex with patients because even though the CIC subpopulation did not participate in the primary endpoint in the Gattex program or even the CLEPA program really highlighting the differences between CIC and Stoma.
The real data — looking closer at that data, it really became clear that the reason for that is the CIC patients start with a lower parenteral score volume at baseline and, therefore, make smaller incremental reductions. And that called into question this 10% threshold for urine output to define who gets to wean. And so that got to a lot of external discussions, which were happening for the last decade, honestly. Could CIC patients participate in the primary endpoint, if they could wean without hitting the 10% endpoint? And that’s what the weaning algorithm is all about. It’s saying, if patients in their weaning have greater than 10% or increasing EUTRx, but they can wean all patients. But if they have less than 10% and they’re a CIC patient, then they go through a bunch of other parameters, like their diet, like their stool, input, their nutritional status or their stool output, their nutritional status, their body weight and all those parameters.
And if they’re all in line and the subject is doing nutritionally very well, then even if they don’t hit the 10%, they could still participate in weaning. The weaning algorithm we used in the STARS nutrition study, and you saw that data presented at UEGW and the patient did very well. Granted a small 9-patient open-label study, but they all did respond and were able to wean. And so, the point to the question you asked about the placebo response is a good question, that’s an open-label study. So, we certainly got the treatment effect from that study. We had a 40% reduction in parental per volume at week 24. That increased to 52% in week 52. And so, we certainly think there’s an opportunity for therapeutic gain. To your point about placebo, we roughly look at the placebo response agnostic of that aspect across the patient population.
So even including what we’ve seen in other studies with the placebo response around the 20%. We think there’s certainly room there for therapeutic gain with the weaning algorithm in CIC patients.
Operator: Your next question comes from the line of Chase Knickerbocker from Craig-Hallum Capital Group. Your line is open.
Chase Knickerbocker : Good morning, guys. Thanks for taking my questions. I actually wanted to start with the LINZESS question, believe it or not. So, a longer one to start. I just want to dig in a little bit deeper on 2024 net revenue guidance. Maybe talk about the different moving pieces that could drive outperformance or underperformance on that guide from a standpoint of the net pricing decline assumptions. So, you guys like pretty confident in those assumptions. Is the assumed pediatric growth driving some increased Medicaid exposure that actually makes that erosion a little bit worse. And what does additional pediatric exposure or different patient mix kind of do to that erosion kind of assumption?
Sravan Emany: I would say our guidance is pretty straightforward and consistent with how we’ve done it in the past years, which is, at this point in time, we’re still anticipating high single-digit volume growth over a very strong 2023. The fact that we’re going to still grow another year from a volume perspective, that’s going to be high single digits. Again, it’s pretty impressive in my mind. We also gave guidance at the JPMorgan Healthcare Conference that we think. And today, we think the price erosion and any other fluctuations will essentially be mid to high single-digit headwind to have low single-digit growth in for the full year. Now if some of those headwinds do not materialize, we could have a year that resembles last year.
