But if I look at ppFEV1, there are hints of that as well, but I would put that lower on the scale of evidence because the variability is greater. With regard to mRNA and why we are so enthusiastic about this program, which we are running in collaboration with Moderna. It is really a combination of three things. The first is the ability to demonstrate that with these LMPs we get the construct into the HBE cells, and that’s important because of how reliable the HBE cells are and how translatable they are. Second, it is about the high expression of the protein, and third, in multiple animal models we can show, and this has been difficult for others to show. Some have not talked about it, and it’s been difficult to gather whether they have or have not.
But I can tell you we have a multiple animal model demonstrated that the mRNA gets to the right cells in the lung.
Michael Yee: Perfect. Thank you.
Operator: The next question will come from Jessica Fye with JPMorgan. Please go ahead.
Jessica Fye: Great. Thanks for taking my questions. Just a couple quick ones, maybe following up on the last. First with the SAD trial for VX-522 completing this year, should we expect to see data from that trial this year or might not come until later once the MAD work is complete. And similar question on the Phase 2/3 kidney trial, you’ve said you expected to complete the Phase 2b dose ranging portion this year. What will we hear at that point? Will we hear anything beyond that a dose has been selected? Will you communicate what that dose is? Thank you.
Reshma Kewalramani: Yes. Hi, Jess. With regard to the SAD/MAD VX-522 NCF, we do expect that the SAD will complete this year. And it’s hard to say that we’re going to see in effect because it is a single dose study, right? But we’ve been wrong before. When patients started on TRIKAFTA, for example, they tell us they felt differently with the first dose. So we do expect that the SAD will finish and we fully expect to initiate the MAD as well. And I do think that we will have a good line of sight on efficacy with the MAD. So we’re not guiding yet to when the data will be available, but we do expect to finish the SAD. We expect to initiate the MAD, and yes, it’s possible that data will be ready this year. On the VX-147 program inaxaplin and the Phase 2/3 study, you’ll remember this one is particularly exciting because it’s in kidney disease where there has been unfortunately very little advancement and there are really no products in development for APOL1-mediated kidney disease.
And our Phase 2 results showed a 47.6% reduction in proteinuria, which is unprecedented in FSGS, let alone in APOL1-mediated FSGS. We do expect that the Phase 2 part of the study will be done this year. Because it’s an ongoing study it’s an adaptive 2/3, which means we’ll roll right into the Phase 3 once dose selection is made. I do not expect that we will be sharing results to maintain study integrity, but we will be sharing that we’ve completed that portion, we’ve selected a dose and we’ve rolled into Phase 3.
Susie Lisa: Thanks. Chuck, we’ll take one more question.
Operator: The next question will come from Iger €“ excuse me, Evan Seigerman with BMO Capital Markets. Please go ahead, sir.
Evan Seigerman: Hi guys. Thank you so much for squeezing me in at the end. I wanted to ask on the IND for the cells plus device program for type 1 diabetes. Can you provide kind of any colors as to what exactly the FDA wants? And maybe colors to why Canada was more comfortable with moving into humans versus the FDA? Thank you.
