Dr. Eric Dube: Thanks for the question. Peter, I will turn to you in just a moment to talk about, to explain a little bit more about, persistence compliance as well as step edits. But before I do, I want to share a story that I have heard from a patient who really talked about their journey with IgA nephropathy. And he shared this at ASN last week. Where I think initially he had some questions or really uncertainties about what a REMS would mean for him. And this was a patient that struggled to get his proteinuria down for years, and his physician offered him FILSPARI. And you can imagine that, like, for many patients, having to go and do additional testing and starting a new therapy, there were many questions. What he shared, and I think was really an uh-huh from many of us in the audience was that, he looked forward to those monthly calls with the nurse from our total care center.
And the ongoing monitoring and support that he felt from our hub services, our patient services, as well as those regular check-ins from his physician. So actually, that may be for many patients a real additional support for that longer-term compliance persistence with therapy. And we know that for many patients, particularly those that are otherwise young, healthy, working, busy, it can be a challenge. So I think that it would really is a real benefit. We have heard lots of questions about the challenges of REMS. I think he did an incredible job to articulate what he found in value of that regular monetary and really people looking after his health. Peter, do you want to share anything further on the persistence as well as the payer coverage?
Peter Heerma: Certainly, Eric, and thanks Mohit, for that question. I think your question was on three components. One was on payer approval, one was on compliance persistent, and one was on REMS if I understood you correctly. So let me go one-by-one. I think really pleased with the payer approval rates that we are seeing for FILSPARI, which closely matches the progress we’re making in the overall coverage as well. So, I think we have made really good progress there. And the compliance and persistence patients are on products in clinical results and remain on product. I know this is one of the questions initially, with the monthly monitoring, will patients remain on therapy? And what we are seeing so far, and it’s still early days, we see strong compliance and persistent rates.
With regards to the REMS and patient perception of the REMS, I think for a large amount of patients, the process is working very well. And these patients receive FILSPARI well within benchmark numbers. But as Eric mentioned earlier, and I was alluding to that in the prepared remark, there’s also a segment of patients that need a little more handholding through education and support. I think you have to realize that it was only until the second half of June, if we had the opportunity to educate physicians and patients other than the package inserts as part of the FDA guidance for accelerated approval. So really by the end of June, we were able to provide that additional educational support for patients. And with additional support, we are seeing that the early REMS certification for that group of patients, it’s already improving.
It also translates them into an increase in full FILSPARI shipments to patients.
Operator: And our next question will come from Carter Gould with Barclays.
Edwin Delfin: Hey guys, you’ve got Edwin Delfin on the line for Carter Gould. Thanks for squeezing us in here. We have a question on pegtibatinase for HCU. I know you’ve completed the end of Phase 2 meeting, but have you guys received clarity from the agency on amount of follow-up and, any impacts on clinical measures beyond the biomarker impact for the primary endpoint? Thanks.
Dr. Eric Dube: Edward. Thanks so much for the question. And we are really excited about our HCU program and moving into Phase 3 here very soon. Bill, why don’t you take that question to share a little bit more to answer those questions, but before I turn over to Bill, I will say that we’ll be sharing much more detail, once we initiate the trial on aspects of the trial design. But certainly, Bill can share what we’ve shared publicly at this point.
Dr. Bill Rote: Certainly, now that I’m off mute, we’ve completed the end of Phase 2 as you noted. We’ve had very collaborative discussions with the agency and I’m happy to report that we’ve aligned as we intended to all along on total homocysteine as the primary endpoint for the study. There are various aspects of the program that look at clinical benefit. Some of those are measures of function. Some of those are quality of life. Some of those will be looking at what we’re able to do with diet. And as Eric said, we’re going to have more detail about this once the study starts, we’ll give you a full picture of the Phase 3 program. And I think you also asked around overall study duration. If we look at the range of other enzyme replacement therapy studies, the period of observation ranges from 6 months to 18 months and we’ll be in that window and most of those studies are less than a hundred.
