Will Kane : Thanks, Bill. I would just add on to that, that to build on those earlier comments about what we refer to as this mental health moment where we see opportunity, particularly in states since the Medicaid population is so important to KarXT, particularly out of the gate, where we see states that don’t require prior authorizations or have 10 or one step. Those would be high priority states. And they tend to be a mix, but some large states are in that mix. So we’ll be fully prepared to capitalize on that opportunity. We will be fully loaded. We’ll have a very robust sampling program, our sales force analysis and structure is nearly complete. So we will go to market, there will be a launch that will support the potential of KarXT across clinicians and payers.
And to this point, and again, that was something Bill said, any engagement we have with the psychiatry community, whether it’s psychiatrist or nurse practitioners, et cetera. There’s a high level of interest and excitement about KarXT and that they’re looking to see our progress and potentially when that drug will be available to them.
Bill Meury : Great. Andrew, do you want to take the second question?
Andrew Miller : Yeah, specifically with respect to the TRPC4/5 program, 2618, at this point, we speak to our focus in MDD or major depressive disorder. We think about that broadly or being broadly applicable to that patient population, we’re not at this point focused on a particular subset of MDD patients. I think we believe that there’s potential benefit from a depression perspective but also from an anxiety perspective. There’s a substantial comorbidity between MDD and anxiety disorders. So that will be a natural place for us to look at the right time for specific benefits given the preclinical and scientific rationale for antilytic and antidepressant effects. But I think at this point, our focus remains on a role applicable sort of potential treatment for MDD.
Bill Meury : Thanks.
Operator: Your next question is from the Jason Gerberry from Bank of America.
Unidentified Analyst: Hi. This is Diana Ann for Jason. Congrats on the progress with the NDA submission this quarter. Just a quick one on KAR-2618. I’m curious as how you’re leveraging all the prior data with this molecule in specifically referring to the molecule failure and the FSGS trial? Was this because it was the wrong target and sort of just what underpins your confidence that it has the right profile for MDD and other CNS disorders. Thank you.
Andrew Miller : Sure. Happy to speak to that. And with respect to 2618, you’re referring to the previous development program that was running in renal disease. Obviously, medications are unrelated to depression or anxiety, but TRPC4/5 being a target that we’ve been following, given the biological rationale and preclinical data, which suggests both antidepressant as well as antilytic effects. We’ve replicated that data specifically with 2618, the molecules are not relying on other target compounds or tool compounds, but specifically with 2618 looking at those preclinical models. So that’s really the basis of our confidence with respect to this molecule. I think it does offer us a great opportunity to leverage the previous human experience with 2618.
Specifically, the program was administered to over 100 humans, 100 patients and up to a duration of 48 weeks. So that provides us a substantial amount of safety and tolerability data that we think is informative and we believe quite positive with respect to the profile of 2618. So given that a molecule substantial previous human experience, given the biological preclinical rationale for potential efficacy in treating MDD as well as anxiety disorders, that’s kind of the basis of our confidence going forward and how we think about designing the right clinical trial to highlight those potential benefits.
Bill Meury : Thanks for the question.
Unidentified Analyst: Thank you. And just one quick follow-up, sorry. So then would you anticipate being able to go straight into Phase 3 trials from Phase 1b given you do have all this prior safety data? Or is it still to be determined? Thank you.
Andrew Miller : Yeah. I mean, I think we don’t want to speculate too far in the future about our development in 2618. But I think what you’re hearing us say is we do think we’re ready to go into a Phase 1b study in patients with major stress disorder. I would say if you look at the program that we’ve run with KarXT in schizophrenia, there’s not a substantial distinction between Phase 2 and Phase 3, our EMERGENT-1 study, in our Phase II EMERGENT-2 and 3 being the Phase 3 studies are identical from a protocol perspective. So again, I think we’ll wait future results from that Phase 1b study prior to commenting to you specifically in our plans going forward from there. But we do think, given the substantial safety and tolerability data that already exists, it does offer us the opportunity to run an accelerated development program for 2618.
Operator: Your next question is from the line of Jessica Fye with JPMorgan.
Unidentified Analyst: This is Nick on for Jess. You previously talked about your commercial preparedness in the U.S. and kind of your thoughts on an initial ramp there. But can you also recap your commercial strategy outside the U.S. and which countries could be logical first choice?
Bill Meury : Yeag. It’s a good question, Nick. Thanks. Outside the United States, we, of course, have a partnership in China with Zai. And then the other two important geographies would be the EU and Japan. And as we said before, we’ll clearly need a partner with regulatory development and commercial capabilities. KarXT has value outside the United States in both of those geographies. And we hope that, that is a strategy that will come into focus in the 2024 period, mid-’24, late 2024 and more to come. Thank you.
Operator: Your next question is from the line of Marc Goldman with Leerink Partners.
