John Newman: Regarding the top line data for SEL-212, I’m just curious as to how much information you might be able to share regarding the safety, specifically the gout flares. I know that some of the early developments suggested that in addition to good efficacy, you may actually be able to improve the incidence of gout flares maybe lower that a bit. Just curious if you’ll be able to talk about that at all, excuse me, on the top line readout?
Carsten Brunn: Yes, that’s a great question, John. And obviously, what’s important to note that we’ve been completely blinded to the data, so we haven’t seen the data, but I’ll let Peter address what we expect in terms of showing the top line perspective.
Peter Traber: Yes, John, I’ll tell you what we expect, but I’ll just clarify a little bit kind of some of the historical data from our program. So first of all, it’s well established that gout flares increase with uricase therapy. That’s been established by — in all of the pegloticase trials that have been done. So you do get an increase in gout flares as you start to dissolve and reduce the urate deposits in the body. In Phase I and early Phase II, it did appear that there was some reduction in gout flares incidents with SEL-212. But in the COMPARE trial, which as you know, was a large comparison trial with 83 patients receiving SEL-212 we didn’t see a real reduction in gout flares. Now in DISSOLVE, we’ll be comparing — we’ll be doing the best comparison because we’ll be comparing gout flares versus placebo.
And we’ll be able to look at the number of gout flares in different periods of time of the therapy versus placebo. So we will have those data, and we’ll be able to report on that.
Operator: The next question comes from Yun Zhong of BTIG.
Yun Zhong: So the first one is kind of a follow-up question on the indication selection for ImmTOR-IL-2. I don’t see the press release specifically mentioned PBC. I just wanted to confirm that PBC is still likely the first indication to choose or I do believe that you mentioned that multiple preclinical I enabling studies will be initiated in 2022 — sorry, 2023. So I assume those studies are for different indications.
Carsten Brunn: Yes. It’s a great — very observant and a great question. As Peter said, I mean, PBC definitely is still part of the mix. We want to open the funnel a little bit and look broader at autoimmune of the liver as there are multiple indications of high interest indications that are well suited for ImmTOR-IL like PBC, where we know the autoantigen impacting the disease, PBC-2, but also there’s other indications with high united, as Peter mentioned, like autoimmune hepatitis. So definitely, PBC is still part of the mix, but we want to open up the funnel and we’ll give more detailed guidance after the DISSOLVE readout.
Yun Zhong: Okay. Then second question on the collaboration with Astellas. It’s a very exciting one. But I believe the gene therapy program uses AAV8 which happens to be the capsid used in the empty capsid study. So just curious, did Astellas show any interest in ImmTOR? And I just wanted to confirm also that ImmTOR and also Xork both of them are agnostic to the capsid used in the study. So the effect is not affected by which capsid to choose. Is that correct?
Carsten Brunn: Yes, that’s a good question. And yes, so Astellas exclusive licensees of Xork for the use in their Pompe program. And you’re also right that both approaches as far as we know, are agnostic. We’ve shown with different AAV subtypes that ImmTOR prevents the formation of losing antibodies. And we assume the same for Xork as a pretreatment, the same that’s agnostic actually to the AAV exposure that patients had.
Operator: The next question comes from Gil Blum of Needham & Company.
