And to your point, you could potentially add another agent that targets upstream pathways but that’s additive. As far as other trials I think it’s important to realize that every other trial is studying a new agent on top of standard of care and many of those trials now because of FILSPARI superiority over ACEs and ARBs they’re being allowed as part of the foundational standard of care. So we will get data over time from these trials as they read out about the combination and them being used together.
Eric Dube: And we certainly are interested in that combination and generating additional data. I’m very proud of Jula’s team, where we do have 2 ongoing studies looking at the combination of FILSPARI plus SGLT2. So I think some of the few combination studies that have yet been initiated, we would expect that, that could potentially increase as other therapies are actually approved.
Operator: Our next question is going to come from Ed Arce from H.C. Wainwright.
Ed Arce: A couple of quick questions for me. Firstly, with regards to the sNDA later this quarter for FILSPARI for approval, just wondering if you could confirm the length of the review period that you would expect 6 or 8 months or would that roll into sometime next year. And then secondly, as I look at the PSFs quarter-over-quarter so far in last year and as those growth rates moderate a bit. I’m wondering if you can discuss some of the 2 inflection points that have been mentioned before later this year, the legal guidelines and the upcoming data analysis from ongoing trials especially the SGLT2 combo. What impact — and I guess this is a question more for Peter. But what sort of subjectively, what impact would you expect those to have on treating physicians as they get more experience with the drug.
Eric Dube: Thanks for the question. Bill, why don’t you take the regulatory question and then Peter, you can take the PSF outlook question.
William Rote: Yes. We expect to have priority review out of for this sNDA that will be consistent with how the agency treated a predecessor that went just recently before us. In that case, it would be a 6-month review, so you’d have a Q3 decision. If we were a standard review, it would take until the end of the year. So in either case, we have a decision this year. I’ll pass over to Peter for the rest of your question.
Peter Heerma: Yes. Thanks for that question. I think there is really 2 elements that I would like to point you to with regards to the evolving landscape, with regards to the KDIGO guidelines as well as a broader label? And what would that mean for the potential for patient start forms in the future. I think there’s 2 core elements. One is the urgency to treat or better the urgency to change with further emphasis has to go lower proteinuria, as a level of [indiscernible] is still not where you need to be. I think last year, the RADAR data got published from the U.K., it’s more of [indiscernible] data and it shows that even with the proteinuria of 0.9, those patients actually have doubled progress to end-stage kidney disease compared to patients that had a proteinuria level of in average of 0.44.
I think this kind of data and then reinforcement in the guidelines further amplifies the urgency to change for those physicians and change that foundation that is currently ACE and ARBs and replace it with a much more efficacy treatment [indiscernible] and just to recall, I mean, the proteinuria benefit that FILSPARI had after 9 months was threefold [indiscernible] but after 2 years, it was actually tenfold. So I think that is an important aspect. So the urgency to change, I think, is one aspect. The second one is really it allows for a broader patient population. And what we have highlighted earlier is that we said at launch, we expect to have an addressable patient population for FILSPARI between 30,000 and 50,000, we think with the broadening of the label as well as further highlights of the guidelines to go to a lower proteinuria target.
We think there is up to 70,000 addressable patients for FILSPARI. I think those are the 2 core aspects I want to highlight with regards to the evolving landscape and what it means for the addressable patient population and potentially patient for FILSPARI.
Eric Dube: Thank you, Peter. Jula, is there anything that you’d like to add?
Jula Inrig: Yes. Thanks. I think we have a couple of inflection points and Peter nicely highlighted KDIGO to treat patients earlier and diagnose them earlier. And then the SGLT2 combination, we know that combination therapy is going to be important in the future. So we think those are 2 things. But the third thing that I want to point out is with regards to the earlier treatment, we have a trial called SPARTAN, where we utilized FILSPARI early after they first get diagnosed and the RAS naive. We presented some of that data at ASN and it shows earlier, we see an 80% reduction in proteinuria most of the patients getting into complete remission and no change in eGFR over 36. That trial has been continuing. We’ll have additional data on that over the years. But I think that’s an additional point as far as treating patients earlier in their disease course.
Eric Dube: Yes. Thank you, Peter and Jula. Maybe if we just take a step back for a moment, if we put ourselves towards the end of 2024 and you assume that we have a full approval with a potential broader label just as the KDIGO guidelines could potentially lower the target and really increase the dynamism in the treatment of patients with IgA nephropathy, we really will be at the right place at the right time. And if you think about also all of the clinical experience that physicians are getting with FILSPARI, there’s one thing that we know from this launch and hearing from physicians and their patients who are on FILSPARI. It is a very rapid and consistent reduction in proteinuria. We believe that we’ll be in the right place at the right time. And I think our goal is to make sure that we continue to expand for new physicians to be able to get that clinical experience and we believe that positions us very strongly for future growth.
Operator: And our next question is going to come from Laura Chico from Wedbush Securities.
Laura Chico: I’d like to shift gears and ask one on pegtibatinase. And Eric, your comments there about kind of the phenomena we see with orphan disease and the expansion of patient populations over time. I apologize if I missed this but do you plan to keep a patient registry with respect to HCU. And kind of related to that, would you be able to disclose an identified patient number as you’re going along?
Eric Dube: Great question, Laura. Yes, we do have a registry and we do continue — we plan to continue that. We think that, that’s an incredibly important source of information for the community. And it’s really a great question around sharing patient information or identification. It’s certainly something we know others have done, we’ll be looking at the potential for us to be able to do that as well. I can’t commit to it today but absolutely something that our team is looking at.
Operator: And this will conclude the question-and-answer session of today’s conference call. I’ll hand the call back over to Anne. Please go ahead.
Anne Crotteau: Great. Thank you, Jenny and everyone, for joining us for our fourth quarter and full year 2023 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day.
Operator: And this concludes our call. Thank you for your participation. You may now disconnect.
