So that’s why we started with DPN. We started with it actually when we did the 150 program and that’s the first PNP or peripheral neuropathic pain indication we pursued when we started with VX-548. As the VX-548 study has gotten started, and frankly as we near that completion, we’ve turned our attention to LSR. It was always our intention to pursue a broad peripheral neuropathic pain label for VX-548, just like we’re pursuing a broad label in the acute pain setting. We recently completed our regulatory discussions on the LSR pain type and gained confirmation that LSR from a regulatory perspective is a PNP pain type. As Stuart said, medically, scientifically, it falls under that umbrella of a peripheral neuropathic pain type. And we completed our discussions with the regulators and confirmed that it is indeed from a regulatory standpoint also a PNP type.
That’s why we’re starting the LSR Phase 2 study now. And I got to tell you, I’m terribly excited about that.
Operator: The next question will come from Phil Nadeau with TD Cowan. Please go ahead.
Phil Nadeau: Hi. Good afternoon. Thanks for taking our questions. A couple of follow-ups from us. First on pain, investors saw the New England Journal of Medicine editorial over the summer that was somewhat skeptical of 548, and it’s a topic of debate. Could you respond to that editorial? What do you think the author got wrong, or where do you disagree with the author? And then second follow up on vanza. In the prepared remarks you mentioned that vanza was going to drive intermediate growth of the franchise. Can you elaborate on those comments a bit more? What new patient populations or opportunities could vanza explore that TRIKAFTA currently can’t? Thanks.
Reshma Kewalramani: Yeah, sure. So when I think about the distillation of the editorial, I think it comes down to this is the holy grail of pain in terms of targets. There looks to be very promising results. It’s a Phase 2 study. How should we think about the magnitude of the treatment effect? How should we think about it in terms of the effect and the potential not only versus placebo, but versus opioids and then maybe a desire to learn a little bit more about the secondary endpoints. And what I would say is we’re going to have a far bigger study, 2,000 people in all. There’s 1,000 people in the abdominoplasty study, another 1,000 people in the bunionectomy study, and another 250 people in the safety and effectiveness study.
And we’ll have all the data we need to make a full assessment in this Phase 3 trial. So I think the best answer is, let’s look towards the Phase 3 trial. And I agree, the Phase 2 results are very promising. Let me turn it over to Stuart to talk about vanza.
Stuart Arbuckle: So on vanza, I would really think about the opportunity for patients to be initiated on vanza to be threefold. One is, people who are currently on an existing CFTR modulator, but if we deliver the sort of profile with vanza that we’re hoping to versus TRIKAFTA, they may want to be switched on to vanzacaftor. Then you’ve got patients who have not yet been initiated on a CFTR modulator. That’s a relatively small number of patients but really the big opportunity for growth is, there’s about 6,000, just over 6,000 patients globally now who’ve actually discontinued a CFTR modulator. So they’ve wanted to be on a CFTR modulator but for a variety of reasons have had to discontinue. As I say, that’s over 6,000 patients now around the world.
We don’t often talk about discontinuations from our CFTR modulators because it’s actually a relatively small percentage compared to any other sort of chronic medication, but it’s still a sizable number of patients. We know they would like to be on a CFTR modulator because they previously tried, and so we think they could be patients who are very interested in vanza if we deliver the kind of profile that we’re expecting.
Phil Nadeau: That’s very helpful. Thanks again for taking our questions.
Operator: The next question will come from Mohit Bansal with Wells Fargo. Please go ahead.
