Right now, we know that obesity is one of the key factors driving that to a lesser extent, its exposure when you take the drug, hence that’s why we’re moving the dose up to 50 up to a 100 in people who don’t achieve goal and we’re using other techniques including artificial intelligence now to identify other factors and ultimately our plan is to develop deliver a toolkit to collect practitioners to figure out who these people are.
Greg Harrison: Great, thank you so much.
David Rodman: Thanks, Greg.
Operator: Thank you. Your next question is from Jack Padovano from Stifel. Please ask your question.
Jack Padovano: Hi. This is Jack on for Annabelle. Thanks for taking our questions. So now that lorundrostat has had data published and presented at multiple medical meetings. How is this exposure kind of help with the interest level for the ASI class overall and do you think that cardiologists and primary care providers are more aware of the importance of targeting aldosterone now than they were before?
Jon Congleton: Yeah, Jack. This is Jon. I appreciate your question. I – I think we’re absolutely seeing an increase in awareness. I think there’s this growing ground swell of interest and focus on aldosterone as really a driver of cardio-renal disorders, whether it’s hypertension, whether it’s CKD, whether it’s heart failure, we’re seeing that grow more and more in awareness and appreciation. I think that certainly tied to some of the really compelling data that’s been put out. Some of it was a bit mixed earlier with Baxdrostat, I think with our data that’s been very robust and showing a targeted effort and even some of the recent data by BI. So I think there’s definitely an increasing interest and – and it’s across the spectrum, it’s cardiologist, it’s endocrinologist, certainly nephrologists and primary care. I think that will just continue to grow as we continue to see more and more data published from subsequent studies from this exciting new class of therapy.
Jack Padovano: Great. And then a follow-up if I may. And this may be a longer term shift in the market but how do you see, GLP ones changing the opportunity for you given their impact on obesity and on cardiovascular factors as they’ve been shown to reduce blood pressure themselves by a not insignificant amount?
Jon Congleton: Yeah. I think it’s – it’s a really interesting point you make as we think about the market writ large, and maybe on that diabetes hyperglycemic sign, SGLT2 inhibitors GLP-1, GLP-1 combo with GIPs. They’re obviously having a significant benefit as it relates to cardio renal would say the blood pressure responses while not insignificant are likely not as robust, is what we have seen in the past with the lorundrostat and what we’re after it didn’t to in a targeted approach. And, again that’s where if you’ve tracked some of the recent conferences, Jack, there’s this growing focus not just on a hypertension alone, not just on CKD alone, not just on hard failure, but on this cardiorenal metabolic syndrome and the fact that there’s an interplay across all of these conditions, and frankly, we think aldosterone is probably one of the key contributors to that broader syndrome and having a drug that can have an effect across those conditions.
We think it’s going to be a three differentiating factor and the GLP-1s may be a part of that, but we certainly believe that ASIs are beginning to show a profile that’s very robust at this stage on blood pressure reduction and potentially on proteinuria and we’ll see beyond that.
Jack Padovano: Great. Thank you.
Operator: Thank you. Your next question is from Seamus Fernandez from Guggenheim Securities. Please ask your question.
Seamus Fernandez: Hi. This is Colleen on for Seamus. Thanks taking our question. You mentioned some changes to the Advanced-HTM protocol amendments to increase randomization rates. Could you provide a little more color there? And if these are considerations will be taken forward to Launch-HTN trial design too. And then secondly, we’ve touched on some of the competitor CKD readouts. Are there any learnings from these trials in terms of trial design or patient population that you’ll be leveraging as you take lorundrostat forward there? Thank you.
Jon Congleton: Yeah. Let me – maybe take the first one on the CKD learnings, and I’ll turn it over to Dave on the changes of Advance and implications to Launch. The CKD, I think as I alluded to in one of the prior questions, what we saw with the BI data, was frankly somewhat anticipated. We know that Aldosterone plays a role again in multiple conditions, CKD being one of them. I think the – the duration of our study that we have planned fits within the profile that we saw within the BI data as far as time to respond. I think the additivity with an SGLT2 inhibitor was anticipated that’s why we built it within our program. So I would say largely what we saw presented this past week at ASN was affirming to the design considerations we put into Explore-CKD. Let me have Dave address your question about Advance and Launch.
David Rodman: Will do. Hi, Colleen. So, good question. When we went into design and execution on the Advanced trial, this was a trial that was design that had only seldom been used, but always acknowledged that the absolute ideal design if what you want at the end is to be able to definitively say you have a treatment for resistant hypertension and hard to control hypertension. And so we were committed to it and remain committed to it. Now we understood though that whatever estimations we made on enrollment were only gonna be just at an estimation and so we always plan to be evaluating that in real time and have the agility to put a protocol amendment in place once we felt like there was justification and that’s really what happened here.
