Joe Pantginis: So I was curious to the extent of the translational data that’s also coming up that you alluded to earlier. And then also now that you’re going to be going pivotal, if you could just remind all of us sort of your capacity to address the manufacturing needs for the pivotal programs and early potential commercialization.
Mitchell Gold : Thanks, Joe. I’ll let Stanford take those, maybe deal with the translational data that has to be presented later on this week and then we can talk about manufacturing and clinical supply.
Stanford Peng: Yes. We have some data at European meeting later this week that will highlight some of the translational data, like expanding on some of the studies we showed at ACR last year, showing the rationale of APRIL and BAFF but also preclinical studies looking at the distribution of the drug in different end organs, demonstrating that povetacicept actually has pretty — quite good penetration and distribution in the end organs compared to wild-type TACI VI, which we think is part of why the drug, at least preclinically appears to look better than wild-type TACI.
Mitchell Gold: And then, Joe, just on the manufacturing questions related to local trials, we’ve been fortunate that we’ve had a very straightforward manufacturing process in POVI . We have all the funds to supply that we need to conduct the clinical trials.
Operator: And we will take our next question from Robert Driscoll with Wedbush Securities.
Robert Driscoll: Maybe a little premature at this point, but how are you guys thinking about the ultimate kind of length of treatment in IgA for povetacicept? I think you’ve mentioned nine months is kind of the important endpoint here for regulatory. How long are you looking at RUBY-3 patients for follow-up?
Mitchell Gold: Well, I think I can therapies in this pathway, I think we’re looking right now, I think, definite treatment for at least initial treatments since we don’t know yet what the optimal duration is. And the drugs appear to be quite limited. So there’s not necessarily a need to limit treatment due to potential side effects. That being said, of course, we’re very interested in the mechanism of the disease-modifying therapy that may induce long-term remissions. So perhaps as a subsequent line investigation, we would then think about exploring a different lens of treatment that may result in long-term responses are hopefully cured.
Operator: And we will take our final question from Andy Chen with Wolfe Research.
Andy Chen : So regarding RUBY-3 enrollment, can you remind us if enrollment is staggered by indication? So we’ve seen a few patients in IgAN. We’ve seen one patient in MN. We haven’t seen LN data. Are we going to see progressively higher ends and newer indications? So are we going to see more patients in MN? And a few months later, we’re going to see another wave of data in LN and then ankle vasculitis, how does that work?
Stanford Peng: Yes. I mean it was not for protocol, but I think the way we operate an study, we focus almost exclusively on IgA nephropathy initially, given part of the prior rationale of the pathway in that disease. And then ANA is actually only recently been formally added to this study. So, that’s the only maybe protocol related restriction and timing. But it was after we saw the encouraging initial data at ASM that we really started pushing on the other indications and, of course, then eventually added, ankle vasculitis in the study. So that’s, like I said, not so much a protocol restricted timing, but more operational focus in terms of the different indications.
Mitchell Gold: And just to add to that, you will see a continuous flow of updates coming out of both RUBY-3 and RUBY-4, and I think that’s one of the benefits we get out of that. Obviously, we’ll get longer term follow-up from IgAN at both the 80 and 240 dose levels. But, we’ll continue to get data in TMN and LN, we’ll see the initial incubasculated data come out. So it will be a trial that continues to support a robust data flow coming out of those basket studies.
Stanford Peng: We did enroll at 80 milligrams. It is a multiple ascending dose study, so 80 milligrams were enrolled first. That’s why, that was the first data set that we announced last fall, and the 240 is lagging behind that, since it’s a ascending dose design.
Mitchell Gold: And that’s per indication.
Operator: And there are no further questions. And so this brings us to the end of our time for questions. Dr. Gold, I’ll turn the call back over to you for closing remarks.
Mitchell Gold: Thanks, operator. I’d like to thank everyone that participated in today’s call. We look forward to seeing many of you at upcoming investor and medical meetings and providing updates in the months ahead. Thank you again.
Operator: And ladies and gentlemen, this concludes today’s call, and we thank you for your participation. You may now disconnect.
