Karl Gubitz: That’s a great question to put the spotlight on the four IND candidates, which are underway to IND before end of 2025. ARGX-109 s a best in class IL-6 antibody, it has phantom order potency with a half-life of at least 60 days, so it’s equipped with our proprietary technologies. And that is, I think, a phenomenal antibody, but we’ve got always a little bit questioning, what is the central role of IL-6 biology in certain diseases? The reason that we give that molecule the goal is because we have seen several indications where we think we see now a clear involvement of IL-6 biology as the driver of disease, not just the bystander, but really try to be the disease. And they are the type of indications which we like to know, they would fit the franchisees we are building and they would basically also be the size of indications which we think we can master very well.
On the second argenx antagonist, people have been asking us what’s wrong with VYVGART, what are we trying to improve. It’s very difficult to improve upon VYVGART, but what we see that there is just more opportunity than we can handle with one molecule. I mean, VYVGART will have an ending life either from an IRA point of view and/or an LOE point of view. And we just want to make sure we have a second very competitive molecule in the race to take on all the abundance of opportunity which we see in front of us. And therefore, we think about a long-term presence in the class, a long-term leadership role in the class and that’s exactly what that molecule will serve.
Operator: Your next question comes from the line of Alex Thompson from Stifel. Your line is open.
Alex Thompson: On CIDP or lead data, I wonder if you could talk a little bit about expectations around when you will present that data? And then how much of it so far has been included in your filing with the FDA? And is there a chance that anything around dosing, every other week dosing would be included in that filing? And if not, at this point, could that potentially delay any timelines here?
Karl Gubitz: For CIDP that these are such important data that we wanted to showcase them as one of the major upcoming neurology indications. So stay tuned. This announcement is waiting for us around the corner. And it’s an important presentation, of course, because it’s the first real innovation in CIDP for a very long time. Secondly, I think the question number two relates to I think, review issue with the FDA. We will need to see how they look at the data. It is through the randomized controlled portion of the trial, it was weekly dosing. In the open label extension, we do have at the auto redosing, but whatever is going to show up on the label, I think ultimately this will be a conversation with the payers. And then you have to expect that argenx will take a position, similar position to what we did for MG.
We will want to price transparently and responsibly and aim for broad access for patients to this innovation. So stay tuned, we will be talking about it in the near future.
Operator: Your next question comes from the line of Samantha Semenkow from Citi. Your line is open.
Samantha Semenkow: I think you recently kicked off a direct-to-consumer advertisement for CIDP in prepared for the launch. I’m wondering if could characterize how you expect this to impact the early launch for CIDP based on your learnings from the MG launch? And then just secondly, I think you’re targeting dermatomyositis with two assets, efgartigimod, of course, in the one of the Akebia cohort and then empa in a Phase 2 study. Can you talk through the rationale for each drug in DM and how you’re thinking about the types of patients that could be addressed with each mechanism of action? Thank you.
Karl Gubitz: I’ll be taking question two. I think Karen has got to comment to talk about our recent DTC campaign.
Karen Massey: Absolutely. Thanks for the question. As I said, we’re getting more and more confidence in the the unmet need in CIDP, as we approach launch and the more that we learn about this market. Certainly from a perspective of preparing for that launch, as you said, we recently launched an unbranded campaign to really raise the awareness, of the burden of CIDP in the community. That campaign is ongoing and leverages the learnings that we had in the gMG launch, that to educate patients and to activate patients is incredibly important in these autoimmune diseases that are underserved, under diagnosed and undertreated. That’s the real goal of the campaign. Thanks for the question.
Karl Gubitz: Thank you, Karen. Dermatomyelitis, look, this as a very high metabolic lead indication, pretty complex biology. When we did the homework on the biology including studying the skin biopsies, you see two distinct subsets of patients and the response subset of patients that you clearly see the involvement of pathogenic auto antibodies of the IgG type, so that is actually perfectly fit for efgartigimod. There is also a subset of patients that you see in the skin biopsy, direct complement deposition and activation without the role of recruiting all two antibody. We think both most of action deserve a short on goal in the end. I think the way we do the studies is there’s a ton of biomarker data involved. Maybe we further unravel this disease biology and we learn how to triage patients, based on the driving disease biology, which is relevant to them.
Operator: Your next question comes from the line of Gavin Clark-Gartner from Evercore ISI. Your line is open.
Unidentified Analyst: Hi. This is Yasha on for Gavin. Thanks for taking our question. We were just wondering what you make of the discontinuation in dermatomyositis and if you see any read through to your ongoing trial? And then I have one follow-up.
