Sean Lee: Great. Thank you for that.
Operator: [Operator Instructions] Our next question comes from Stephen Willey with Stifel. Please proceed.
Stephen Willey: Yeah. Good morning. Thanks for taking questions. Maybe just a couple Phase 3 CN questions. So, I think, you are stratifying on CN subtype in the Phase 3, but I guess I’m just wondering how you expect those subtypes to be represented within the Phase 3 given patient eligibility criteria and if you’re enrolling in a way to get kind of a minimal representation of each of these, whether it’s congenital, autoimmune or idiopathic.
Dr. Christophe Arbet-Engels: So, yes, this is Christophe here. The included criteria will have congenital, idiopathic and/or autoimmune patients. In the study, we will have the patients on monotherapy and on GCSF as well. We’re not planning on stratifying specifically for some of those subtypes, but we’ll do additional analysis obviously when we have given the sample size. We’ll have a substantial number of those subtypes that we’ll be able to consequently analyst — analyze.
Dr. Paula Ragan: Yeah. And just to add to Christophe’s comment, that the idiopathic autoimmune are essentially the same bucket. They’re different words for the same group of patients and that’s quite a large majority and then there’s the congenital. So, we’ll be able to stratify by those bigger buckets. The congenitals are so variable, it’s really we’re not able to stratify based on the heterogeneity of congenital. So, we’re stratifying across the big buckets that Christophe mentioned and also GCSF and monotherapy.
Stephen Willey: Okay. And then is there a lower limit of neutrophils that a patient must have to be Phase 3 eligible? And then I guess just given the inherent variability of neutrophil counts, how many measurements do you require during the screening process prior to randomization?
Dr. Christophe Arbet-Engels: So, yes, we do have the — so the measurements first. Let me start with this. We have several measurements that we’re going to be looking at. For the screening we’re looking at one measurement on the screening and then we will establish the baseline on several hours of measurements. And the first part of the questions was if there is a lower limit of ANC. We don’t have a lower limit of ANC. There will be some patients that can be fairly low, especially in the congenital population and we have a range that in our inclusion criteria that include those severe all the way to the mild and moderate neutropenic patients.
Dr. Paula Ragan: And Steve, just as a reminder of benchmark, our WHIM Phase 3, their baseline were about 180 cells per microliter, so quite severely neutropenic. So, we would expect to be able to accommodate patients certainly well into those ranges and hopefully to see an effect similar to what we’ve seen in WHIM.
Stephen Willey: Okay. Very helpful. Thanks for taking the questions.
Operator: The next question comes from Kalpit Patel with B. Riley. Please proceed.
Unidentified Analyst: Hi. Good morning. This is Jay [ph] on for Kalpit. Thanks for taking the questions. My first question is for the upcoming Phase 2 update. Where we see data from patients who are on higher dose or GCSF. Believe the data staying to-date were for patients less than 1 microgram per kilogram by the approved dose of a GCSF is much higher? And my second question is for the Phase 3 that you are planning to start. What in your view is a good delta for reduction in infection rate versus the control arm? Thank you.
Dr. Paula Ragan: So, we’ll tag team here. I mean, so in terms of the GCSF dosing, you’re incredibly sharp in assessing that the average dose of GCSF of the patients is much lower than the labeled dose and that is practice. Unfortunately, this drug is so challenging to take and to manage that physicians and patients stay on the very low end, sometimes as low as 20% of base of the labeled dose. And again, we don’t give guidance on what doses patients are on. They come in at their own stable doses. So, we would expect if that’s the standard of care, that that’s the range that we’ll continue to see in the trial. So, I hope that addresses your first question. And then I think your second question was around what type of infection benefit target are we aiming for in the Phase 3?
Dr. Christophe Arbet-Engels: So, in our Phase 3, I want to remind you about our WHIM data. Our WHIM data on average have seen an improvement of 60% of infections and we’ve taken a rather conservative approach and we’re estimating with power of that study for 40% difference in annualized infection rates.
Unidentified Analyst: Okay. Thank you. That’s very helpful.
Operator: Thank you. At this time, I would like to turn the floor back over to Paula Ragan for closing comments.
Dr. Paula Ragan: Thank you so much for joining us today. We appreciate all the attention and insightful questions and wish you an enjoyable rest of your day.
Operator: Thank you. This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation and have a great day.
