Travere Therapeutics, Inc. (NASDAQ:TVTX) Q2 2023 Earnings Call Transcript

Alex Thompson: Great. Super helpful. Thank you.

Eric Dube: Thanks Alex.

Operator: Our next question comes from the line of Ed Arce with H.C. Wainright. Ed Arce, your line is now open.

Ed Arce: Great. Thanks for taking my questions and congrats on the progress in the quarter. A couple for me really just to follow-up on some prior questions. First, with regard to meeting with the FDA later this year on FSGS, I wanted to get a little bit more granularity around some of the scenarios or perhaps proposals that you’re coming to the meeting with, in particular whether a new trial would include more patients or higher power or perhaps a longer lead-in period or some other aspects that would better correlate proteinuria with the long-term outcome of eGFR. And then secondly, around the label expansion in IgAN, just wondering if you can put some type of a quantitative description around the incremental size of patients if you go down from the 1.5 grams now to the one gram after label expansion? Thanks so much.

Eric Dube: Ed, thank you for the question. Maybe I can take a stab at the FDA scenarios. I think fundamentally, we’re looking for FDA to align on our view that the totality of data that we’ve generated to date with sparsentan in FSGS would be sufficient for us to submit an sNDA. I don’t really foresee that we would undertake a large trial at this point. I think that the data that we have is sufficient. Jula, would you like to add any other color to that?

Jula Inrig : I would echo what Eric had to say. And really this is our first meeting with them, them being able to see the data the totality of results that we’ve generated in a patient population that really has very little else available to them, and a really consistent safety profile and a consistent and durable effect on proteinuria and positive trends on many other meaningful end points. That’s really just to have a first conversation to show them the data and have a discussion about next steps.

Eric Dube: And Peter, would you like to take the question about the expanded population.

Peter Heerma : Sorry, can you repeat the question? I missed that.

Eric Dube: Yes, the question is quantifying, how many additional patients might there be with the expanded label for IgAN at full approval?

Peter Heerma : Yes. I think it is important to realize that that even though the label is right now for patients at high risk of disease progression, generally with a proteinuria higher than 1.5. That doesn’t exclude patients below 1.5, because there may be other factors why the physician determines that a patient is on a path of rapid progression. So we see also utilization below 1.5. But I think to the point that I made earlier on the call with the broadening of the label we also will see a broadening of the prescriber base, because I think that provides further confidence in the profile and opportunity for communication. And as Eric mentioned earlier, initially in the launch often you are being prescribed in patients that have not had success with any other treatment options. And as physicians start to see what FILSPARI can do and means for their own patients that stimulates repeat prescription as well. And that’s what we start to hear and that’s really pleasing.

Eric Dube: Yes. I think maybe the only other thing I would add is, I think, there’s going to be two factors for us assuming that the addressable population now with 30,000 to 50,000 expands given that there are up to 150,000 patients in the U.S. with IgA nephropathy. I think fundamentally, it’s going to be the addressable increase of those patients that are below 1.5. And I think a very compelling data set that we now have that Jula shared from the RaDaR analysis reflects that even patients that may have been considered low risk those patients that may have 0.5 grams, there’s a proportion of them that are at risk of progression. So I think there’s going to be increased awareness of who’s at risk as well as earlier diagnosis as we have more education in IgAN in the years to come.