And of course, then we have all the other data along the way, which is highly supportive, gives a kind of sensitivity analysis and really confirms that will confirm that the validity of the results collected at the end. And that was €“ this is the same methodology that we used in the ENHANZE study the same instrument, the same electronic device.
Sujal Shah: And then the only other thing to add there Steve is, historically in north of 100 patients in our open label Phase 2 study and the 265 patients randomized in our ENHANZE study, we’ve seen about 30% of patients have an NRS of 4 €“ about approximately 4 or greater at baseline. This is that moderate to severe age population pre-specified to measure this secondary endpoint. We expect to see a similar proportion in this study as well.
Steven Seedhouse: Awesome. Thanks so much, guys. Appreciate it.
Sujal Shah: Thank you.
Operator: And the next question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.
Kristen Kluska: Hi, good afternoon. Thanks for taking my questions. So, the first, I saw that the global PBC study group is having its 10-year anniversary meeting next month. And one of the debates listed in the program was around normal ALP, which you touched on earlier in Q&A. But one of the other debates listed that caught our eye is just on whether starting a second line therapy should be conducted at 6 months or before? So, I was wondering what your thoughts on this might be, especially now that physicians might be getting closer to having another therapy if you are successful? And then anything else at this conference or event that you’re focused on given you’re very close to the data now?
Chuck McWherter: Yes. Thank you for the question. Kristen, yes, we’re all very excited. Many of us will be in attendance. It’s going to be a great meeting. In terms of when should patients be treated, I think that there has historically been this somewhat arbitrary time point at one-year where you try UDCA for a year and some of the thinking was well maybe for some patients, it takes a little bit longer than others. Increasingly, there’s been a lot of research that’s challenged and examined this. And in particular, I know that there’s been work-out of the global PBC study group that has said that even at diagnosis, if you have a level that is right around 2x upper limit at normal, there is no reason to wait, at least not wait for a full-year.
And so, I know that there was a manuscript that was prepared. I don’t know if it’s been published yet, but it really shows that the benefit versus the risk, especially for a drug like, for some of the second line therapies should be taken into consideration. The second part of your question?
Kristen Kluska: Is there anything else at the conference or event that you’re keenly focused on?
Chuck McWherter: Yes. So, I think you’re going to see a lot of discussion from these thought leaders who are €“ many of which sit on the guideline committees. So, we expect to hear a lot about different risk considerations that should influence what guidelines say and when treatment is started? And how risk is measured? So, I think alkaline phosphatase normalization as you’ve already mentioned is going to be a key consideration. There are other risk strata that are increasingly and quite often being discussed. Higher risk bilirubin, which means bilirubin levels that are in the normal range, but at the higher end of it. So, between upper limit at normal is recognized as carrying greater risk for progression so patients can be low or below that 0.6x upper limit to normal, along with normal alkaline phosphatase levels, it seems that they can be put into a situation where their risk is the same as healthy subjects.
