Operator: The next question comes from Yaron Werber Cowen.
Yaron Werber : Just on SPINRAZA, the response by the interim results are definitely encouraging. Can you give us a sense, are these potentially label-enabling? Like how do you think about it just given your broad label? Do you need sort of label enabling? Or is this just for standard of care sort of change? And then secondly, just in terms of some of the ATXN2 program and the ATXN3 programs. I know you touched a little bit on ALS. You also have a fast program for ALS. Just maybe give us a little bit of a sense what’s the next timing and what do you expect from the data? I know the fast ALS is a pivotal in 2025 or the other 2?
Brett Monia : Yaron, so is our understanding that ASCEND or RESPOND — responding the data you’re talking about verging data, patients that haven’t done that well on gene therapy moved on to SPINRAZA and really showing really good strong signs of doing very well, improving muscle strength, neuromuscular function. Not surprisingly, there’s been a lot of anecdotal data out there over the years that this is the case, but it’s very helpful to that biogenetically did a study just to demonstrate how the study is ongoing. It’s our understanding that these studies and patients that perform suboptimally on either gene therapy or on that a SPINRAZA will be more for publication purposes and those sorts of things and which are for certainly in line with promotion.
It’s the DEVOTE study that has the potential to actually expand label. The DEVOTE study is a randomized controlled Phase 3 study looking at higher doses of SPINRAZA to demonstrate even greater efficacy in SMA patients of all kinds. So that’s my understanding. So I’m getting head nods from my clinical folks here so. Eric, just reminded me, I didn’t answer the ATXN2 question, Yaron. So the ATXN2 is enrolling for dose cohorts. The top dose is an expanded cohort to have more patients in the dose that has the potential to be the dose that goes to Phase 3. That data is due to read out midyear next year, ATXN2 for non-genetic ALS. I’m sorry.
Operator: The next question comes from Luca Issi with RBC Capital Markets.
Luca Issi : Maybe if I may, following up on the prior question and Brett, you may have already alluded to it, but I want to make sure was [indiscernible] in-licensed the next-generation molecule informed in any sort, form or shape by the blinded event trade that they’re seeing in the cardiovascular outcome trial pelacarsen or is this just truly life cycle management? Question to maybe, Eugene, if I may, on TTR cardiomyopathy, wondering if you could comment on what statistical methodology are you using for the Phase 3 for TTR cardiomyopathy are using your Finkelstein-Schoenfeld method similar to BridgeBio and Pfizer? Or are you using the Andersen-Gill method, which is similar to Alnylam and maybe why you choose one versus the other? And then lastly, maybe on AGT, what was your reaction to Alnylam-Roche deal and how you’re thinking about BD for your molecule?
Brett Monia : Sure, Luca. Before turning it over to Eugene, I’ll take through those, and then you can talk about the statistical plan for CARDIO-TTRansform. So Lp(a) entirely life cycle management. The pelacarsen Phase 3 study is going very well on track for data in 2025 with a potential filing in 2025 has nothing to do with any particular data from the study, except to say that the study is going very well. So that lends even greater confidence by Novartis to pursue life cycle management. We’re focused Luca on our own programs, really don’t have a reaction to any competitors in the AGT space or anywhere else in partnering strategies. We — our plans haven’t changed. We are planning to share new AGT data in the second half of this year at a medical meeting.
