We’ve seen that so far. But of course, obviously, something we’ll watch very carefully in those patients is where we are in terms of the limit of detection for the assay, but that’s something we’re very thoughtful about. Of course, we don’t know if that happen in Stage 2 patients as those are patients that, of course, are going to be a bit further in their progression and we’ll be — will likely have much higher baseline in Huntington protein levels that will make that sensitivity issue really not an issue.
Unidentified Analyst: Thanks so much.
Operator: Thank you. One moment for our last question and it’s from the line of Joseph Schwartz with Leerink Partners. Please proceed.
Joseph Schwartz: Thanks so much for fitting me in. So I wanted to ask since it’s been a while since Kuvan and pegvaliase were approved. I was wondering whether for sepiapterin, you’ve been able to establish with the FDA that data focused on Phe lowering will be sufficient and that clinical outcome assessments won’t be required for approval in PKU? And then I have a follow-up.
Matthew Klein: Yes. Joe, obviously, one of the most important things we did prior to commencing the Phase 2 study is to make sure we have full alignment on the study design, including the primary endpoint of Phe reduction. I think traditionally, if you look at the FDA when they have made a decision on approval based on something that doesn’t change with time, it actually gives them confidence that they can interpret your study results in a meaningful way. So, we, of course, make sure that there was alignment on Phe as the endpoint — Phe was the endpoint. And of course, we’re very happy to have seen not only that we had a significant effect. But as I’ve talked about earlier on the call, results are highly statistically significant and much greater magnitude than we’ve seen with previous oral therapies.
So, I think that becomes very easy for them to see the not only statistically significant, highly clinically meaningful benefit that we’ve been able to demonstrate in the APHENITY trial. And of course, one of the elements of the pre-NDA meeting was ensuring that we had the safety and efficacy data that’s necessary to support that NDA submission and the answer was yes. Yes, we do.
Joseph Schwartz: Okay. And then since strong patient advocacy seemed to be key for SKYCLARYS to get traction with the FDA, who wasn’t on board with Reata being able to file. At first, I was wondering if you could give us any insight into how much the FA patient or physician community has been lending support behind your effort to pursue a filing sort of to take one out?
Matthew Klein: As I mentioned earlier, John, I think the Friedreich ataxia community led by the Friedreich Ataxia Research Alliance is really a model disease community in terms of aggregating the patients, the physicians as well as industry and being able to really lead the charge in ensuring that this therapy developed and develop successfully for the treatment of Friedreich ataxia patients. I’m proud to say that we have partnered with — since the beginning of the clinical development, in particular and ongoing many years back, and we’ve been incredibly grateful for their partnership, not only in helping us understand how to best design trials, their work in establishing a patient registry that will obviously be very important in us putting together a data package for NDA.
And quite frankly, the work that they’ve helped lead with the physician community and research community on demonstrating the importance of upright stability for pediatric and adolescent ambulatory patients. So, I can proudly say that they’ve been a partner of ours and we think that’s been an incredibly important part of the vatiquinone journey, and we think it will continue to be — that partnership will continue to be an important part as we move forward and look to submit an NDA.
Joseph Schwartz: Great. Thank you.
Operator: And thank you. I would like to conclude the Q&A session now. And thank you all who participated and turn it back to the CEO, Dr. Matthew Klein, for additional comments.
Matthew Klein: Well, I just want to thank everyone again for joining the call today. As we discussed, we look forward to an exciting 2024 with a number of important and valuable potential milestones ahead, and we look forward to sharing the journey with you all as we move forward. Thank you again.
Operator: And thank you all for participating. And you may now disconnect.
