argenx SE (NASDAQ:ARGX) Q4 2022 Earnings Call Transcript

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Yatin Suneja: Good morning, everyone. Keith, that’s been great working with you. Good luck with the future endeavor. So just following up on a question on the CIDP. Could you provide some detail on the baseline and cap score that you showed or you might be expecting in Stage B? And the reason I ask is because, for the first 40 patient in ADHERE the baseline was around five, which seems to be a little bit higher than previous study. And there seemed to be this inverse correlation between a high score and probability of relapsing. So just trying to get a sense of how the placebo might perform? Is there a particular score that you are looking for? And then the second part is like, what about the maximum number of patients that can be enrolled in Stage B? Thanks.

Tim Van Hauwermeiren: Thank you, Yatin. So on question 1, I need to wait for the answer also until we unblind the study and we look at the data. I have no further information above and beyond what was historically disclosed. And it’s also very difficult to compare apples with apples in between the IV trials and the ADHERE trial. There is probably a difference in placebo response. But it’s premature for us to comment on that. So let’s wait until we unblind the data. Is there a limit to how many patients we can enroll in Phase B? No, there is no real limits above and beyond the numbers, which we highlighted for enrollment on clinicaltrials.gov. And then you can see that we basically stopped screening for the study, we feel that we have handful of patients which now made it into the funnel. So let’s see. Let’s wait. This is a Q2 event as far as we can see today. And let’s look at unblended data together soon. Thank you.

Yatin Suneja: Very good. Thank you.

Operator: Your next question comes from the line of Myles Minter from William Blair. Your line is open.

Myles Minter: Hi. Thanks for taking the question. Just on — you mentioned you stopped screening the study for ADHERE. Is your screen out rate when you do the independent investigator sort of confirmation of the VYVGART scores? Has that remained consistent with what you presented at I think it was about a 50% screen out rate. Has that remained consistent with the patients that you’ve been enrolling beyond the 120 to 130 range? Thanks.

Tim Van Hauwermeiren: Hi, Myles. Thanks for the question. My information is that, that screening failure rate continues to be consistent. So it is around 50%. It is also perfectly in line with earlier published studies looking at the accuracy of the CIDP diagnosis. So we feel it’s in sync with real world. And we think that it is constant throughout the study. Thank you for the question.

Myles Minter: Thanks.

Operator: Your next question comes from the line of Manos Mastorakis from Deutsche Bank. Your line is open.

Manos Mastorakis: Yes, hi. Thanks for taking my question. So I wanted to ask first of all in terms of the priority review voucher and the unwanted scenario of an FDA rejection? What happens to the priority voucher? Do you get it back? And maybe a quick follow-up on whether you have any data on duration of the second cycle that is patients going from second to third dose? Thank you.

Tim Van Hauwermeiren: Keith, would you mind starting with the second to third dose, the relative distribution we see in the real world. And then I will take on that question on the PRV. Thank you.

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