Seamus Fernandez: Great. Thanks so much. Appreciate it guys.
Operator: Thank you. And our next question comes from the line of Mohit Bansal of Wells Fargo. Please go ahead. Your line is open.
Unidentified Analyst: Hey this is Adam [ph] on for Mohit. Thanks for taking our questions. My questions are for David, with regard to the OLE study. I’m trying to understand, firstly, in February a single-arm OLE you’re pursuing, one that includes a treatment withdrawal sub study. So I wanted to understand what you could ultimately kind of drop from that approach there. And then secondly, does the inclusion of CKD patients in the OLE give important around hyperkalemia risk? Or was this pursued for another reason?
David Rodman: Okay. Well, thanks for the questions. And so just to break it down in its component parts. The first question was about the randomized treatment withdrawal. So the FDA requires that we do a randomized treatment withdrawal. And what that means is anybody who is in the open-label extension on active — and obviously, they’re on active drug who has a benefit on blood pressure. So they’re informative, would then have — be randomized to either stay on drug or go on placebo. They don’t tell you how many, but it will be in the hundreds of subjects that go through that. The purpose of it is just to see what you would refer to as an on-off on approach. In other words, they come in on a certain amount of drug, they go off it, then they go back on it.
How reversible are these things, how — what time course, etcetera? We know our drug has a major advantage in that it’s only got about a 10 to 12-hour half-life meaning that things like hyperkalemia, we can turn off and on very quickly, but we also can restore normal circadian rhythm. So Aldo goes up and down the way it’s supposed to. And so that’s what that’s for. So we expect to learn a lot about those details, but primarily, it’s because it’s a requirement as well. So let me just stop there for a second. Did that answer your question, that part?
Unidentified Analyst: Yes. Thanks.
David Rodman: Okay. So another part of your question was about putting CKD patients in. What we’re doing from a logistics standpoint is having one omnibus open-label extension. But we don’t — we have to have an integrated safety database of every single patient who got even one dose of drug and and there it’ll be included in that. But beyond that, they’re going to be a separate cohort that’s analyzed within the trial. And so we’ll be able to say, for instance, in subjects whose eGFR started at 30 to 45, what was their relative risk of a change in potassium. And that’s very important because when we talk to experts at these referral center sites, I mentioned, they’re not in the least bit worried about potassium. They deal with it all the time.
They use the new potassium binders, and they just want that blood pressure to go down. So we’ll be able to provide those data in that subset and then for primary care docs who may see somebody with an eGFR 60, they really don’t want that patient’s potential to go up over a certain threshold because they’re in a different space in terms of management. And so we’re going to have very, very good control over saying in this subset, here’s the safety profile and this other subset, here’s the safety profile. So I don’t think we have concerns about suddenly getting a warning that you might get a high potassium. It’s in fact just the opposite. We’re going to have a very informative set of data to go into the label.
Unidentified Analyst: Appreciate the detail.
Operator: Thank you. And there are no further questions in the queue at this time. So this concludes the question-and-answer session. And I’d like to turn the call back to Jon Congleton for the closing remarks.
Jon Congleton: Thank you, operator, and thank you, everyone, for joining us today. We’re very excited about the progress we’ve made over the past year in advancing our clinical programs and remain enthusiastic about the upcoming milestones for the rest of the year and into 2024. We look forward to updating you as our pivotal program for lorundrostat continues to advance. With that, we’ll close the call.
Operator: Thank you. This now concludes the conference. Thank you all very much for attending. You may now disconnect your lines.
