What we also know is that during the first year, you saw about a 30% discontinuation rate with Vox. We don’t actually have specific numbers for Crinolizumab discontinuation rates in the first year, but you could assume that it’s probably similar to Vox, maybe a little bit higher because it does require infusions at an infusion center. So doing all of that math gets you to around 75 to 10,000 patients. Where that number may be overestimated is the fact that not all of those patients meet the patient severity criteria, but where that number may be an underestimate is the fact that it doesn’t include any prescriptions in 2023. We only have prescriptions through 2022. So taking all of those numbers into consideration, that’s how we arrived at the 75 to 10,000 patients in the US that meet that inclusion-exclusion criteria, which represents about 7.5% to 10% of the total 100,000 patient population.
Did you want to address your second question?
Iain Fraser: Yeah. So this is Iain. We haven’t projected a screen fail rate at this point. I can tell you that for the initial phase of the study where we recruited 16 patients, that screen fail rate was a little over 50%. So it was a relatively high screen fail rate at that point and we’re sort of carrying that forward at the moment, even though patient population is likely to be more severe. We have more experience with the sites and with the education of the sites around the protocol and so expect to be able to help with patient selection in that fashion.
Joe Schwartz: That’s very helpful. Thanks for all the insight.
Iain Fraser: Yeah. Thanks, Joe.
Operator: Our next question comes from the line of Edward Tenthoff with Piper Sandler. Your line is open.
Edward Tenthoff: So no one ever asks a question on poor little losmapimod. So I guess I’ll be the one to ask it. With all of the — with the data coming in the back half next year, what are some of the commercial prep that you’re doing and as you kind of project out here, what’s the calculus between keeping it and launching it yourself, partnering it, maybe partnering it overseas? Just update us on sort of where your head is on that? Thanks.
Alex Sapir: Yeah, absolutely. Thanks. Thanks so much for the question, Ted. And I appreciate you asking a question on losmapimod. Thank you. So, yeah, so just as a quick reminder, we would have — we plan to have top line results in the fourth quarter. We would then file the NDA sometime in early 2025 for an approval sometime in 2026. We’ve been very clear that we believe that we can launch this drug quite successfully in the US with a fairly sort of modest commercial infrastructure, while at the same time looking for partners ex-US. And we will begin the process of sort of standing up that commercial organization the end of this year, beginning of next year, starting with our first kind of key hire, which would be that cheap commercial officer.
And I think one of the reasons that we’re so excited about our ability to be able to do this ourselves is, it’s a fairly sort of concentrated market. It’s a fairly small number of neuromuscular specialists that treat these patients with FSHD. They’re very, very well organized from a patient advocacy standpoint and we have an excellent relationship with the FSHD society and the fact that there are currently no treatment options and the drug that’s probably the closest behind us is probably two to three years, Roche’s product, that’s a myostatin inhibitor, it’s two to three years behind us. We believe that we really do have an opportunity to be successful with this launch in the US, doing it ourselves, and then the ability to help a tremendous number of patients in the US as well as working collaboratively with a partner ex-US to help patients around the world.
Edward Tenthoff: That’s super helpful and I do think it’ll garner more attention as we get into the new year. So thanks for the update.
Alex Sapir: Yeah, thanks, Ted.
Operator: Our next question comes from the line of Matthew Hagood with Oppenheimer and Company. Your line is open.
