Chris Morabito: Yes. Eun, thanks for these questions. So in terms of data, we are anticipating proof-of-concept data in mid-2024. The proof-of-concept data should be able to demonstrate that we are in target to achieve our target profile, which, as you know, is reducing effects when given every 3 months or potentially every 6 months. So while I can’t guide you today to what we anticipate showing in mid ’24, I could tell you that we are looking to be able to show data that would support that kind of profile. Regarding your question about endpoints, the proportion of people who are attack-free is a meaningful important endpoint. It is possible that with this profile, given its PK curve, and as you know now the PD effects for at least 84 days, that we can show a substantial people — number of people that have no attacks compared to baseline.
And if we do have compelling data, meaning high integrity data that are capable of showing that, we would be pleased to be able to show that.
Eun Yang: Yes, I’ve one more follow-up. So clinical sites in the U.S. and Canada up and running, and it sounds like the patients have been enrolled as we speak. And then European sites to open this year. When you enroll patients, do you have to enroll in sequential from quarter 1 to 3? Or can you actually enroll patients simultaneously from cohort?
Chris Morabito: Right. So with the protocol as written calls for safety check need for, we start Cohort 2. That’s the one requirement that’s in the protocol so far. Beyond that, it is possible that we can enroll one and not completely fill it before we start the other. At this point, we anticipate not enrolling all three at the same time for a variety of reasons, the most important thing just the accumulation of data. So while the answer to your question is mixed, we don’t have to go exactly through each one to start the next but we are staggering the start of Cohort 2.
Eun Yang: Do you have a kind of a ratio in terms of number of patients are being enrolled in the U.S. Canada versus Europe?
Chris Morabito: I don’t.
Eun Yang: Okay. Thank you very much.
Chris Morabito: You’re welcome.
Operator: Thank you for the questions, Eun. So our next question comes from Michael Higgins from Ladenburg. Please go ahead, Michael.
Michael Higgins: Good morning, guys. Thanks for taking the questions. A question on the cohorts in Phase 1a. Are there triggers for adding cohorts in ALPHA-STAR? If you can share with us, we appreciate it. Thanks.
Andy Nichols: Michael, could you maybe clarify your question, the Phase 1a data to trigger ALPHA-STAR?
Michael Higgins: Yes, Andy, in Phase 1a, there were additional cohorts added obviously from the first three to the next two. I’m wondering if there any triggers to add additional cohorts in ALPHA-STAR.
Andy Nichols: So we’ve added the possibility to add cohorts to ALPHA-STAR. Actually, that’s been sort of in our mind from the beginning. We’ve done that now with adding Cohort 3 to test the feasibility of a regimen that could achieve the potential for every 6 months dosing. There aren’t any a priori defined triggers for additional cohorts. However, if evolving data from our trial or from the Phase 1 show that there might be additional questions to ask, we do have that possibility.
Michael Higgins: Okay. And then one follow-up. Are you doing anything in the current trials or potentially future trials to reduce injection site reactions? Hasn’t been a major issue so far, but curious your thoughts there. Thanks.
