We’ve also been working incredibly closely with the HAE physician and patient community. This space is fortunate in that the advocacy organization that is based in the U.S. with outreaches throughout the world on the HAEI is fairly strong, has an active community, works well with us as a partner and is helping us think about how to operationalize the study in a way that makes sense for people living with this disease. We’ve been working with the physician community to understand how best to talk with the community about their potential participation. And the final point is that it’s a global trial with a big footprint. We have — I think we’ve now been pretty open about this. We have lots of sites that we are targeting to participate in this trial.
And we hope that even if sites find just one patient to potentially participate that we will be able to enroll this in a way that meets our operational guidelines.
Joe Pantginis: That’s very helpful. Thanks. And I guess when you look at these, the data you have and the plan that you have for ALPHA-STAR and the long-term dosing intervals, how do you look to present the data and also the potential impact on any statistics you’re looking at with the potential or anticipated, albeit small anticipated, needs for the rescue meds?
Andy Nichols: Yes. So what we anticipate is that we will have proof-of-concept data in mid-2024, and that will include the initial data from all three of these cohorts. So the dose initial data would be able to communicate what we think would be meaningful for the community. And what we would like to be able to show is that the profile is — from a safety perspective, is favorable that there aren’t any additional or unexpected safety findings that we have robust durable reduction in attacks, in this case, measured from baseline, change from baseline and attack frequency, that we have PK and PD that’s supportive of the clinical and safety findings that we’ve been describing and that we have a meaningful and positive impact on quality of life.
This is a disease, and as you know, from other trials, this is a disease that in proof-of-concept trials using a small sample size that allows for a demonstrably meaningful representation of data. Typically, in Phase 1b/2 trials in the space, cohorts are about four to seven subjects, and that’s exactly where we anticipate being here with the option to add more if we need to. The reason for that is that we anticipate a very large effect size. Lanadelumab, in Phase 3 are showing about 85% reduction compared to placebo. That size in terms of change from baseline allows for a smaller overall sample size. So even with this few number of subjects in each cohort, we anticipate being able to demonstrate that this has the potential for meaningful effects to the patients.
Joe Pantginis: Okay. Thank you.
Operator: Thanks for the questions, Joe. Our next question comes from Eun Yang from Jefferies. Please go ahead, Eun.
Eun Yang: This is Eun. Can you hear me okay?
Operator: Yes, we can.
Eun Yang: Thank you. So the proof-of-concept data that we are expecting mid next year. So you mentioned the all three cohorts. So how many months of follow-up are we expecting when we see the data? And then second question is the — you mentioned it’s a safety tolerability PK/PD changes in PED rate. Because it’s a single dose, we are not going to see — almost certainly, we are not going to see all PED 3 rates in this study, correct?
