And then lastly, I acknowledge this is still quite early, but in terms of pricing, my question is, how €“ just talk us through your thoughts here, how do you balance the need to allow for broad unencumbered patient access with the desire to capture the full clinical value, if for example, the key secondary endpoints are shown to be strongly positive? Thanks so much.
Sujal Shah: Appreciate the questions, Ed. And maybe I’ll start-off and Lewis can add on the first question here with respect to some of the work that we’ve done, very early work. It’s work that continues on today from a market research perspective and we’ll continue through the readout of response as we have confirmation, if you will, potentially of the target product profile that we believe seladelpar may have if we are successful and look to register. When we look specifically at seladelpar versus obeticholic acid. First, I think it’s important for me to point out that anything I described to you here doesn’t come from head-to-head data, but from cross study comparisons. So, with that important caveat, what we’ve seen thus far in what we believe are similar patient populations is the ability for seladelpar to bring a greater proportion of patients to goal as it pertains to alkaline phosphatase below 1.67x the upper limit of normal and normal bilirubin whether we’re looking at 3 months or 12 months or beyond.
We also see a greater proportion of patients generally that are actually experiencing normalization, which we’ve talked quite a bit about already. And then as you mentioned, some potential favorable effects that could be, we think very significant with respect to effects on reducing pruritus symptom burden and therefore potentially improving quality of life for patients. That’s a differentiator not just from obeticholic acid, but even from first-line treatment with ursodeoxycholic acid, which has never been shown to actually reduce itch. And then finally, just thinking about overall safety. Now, we continue to evaluate safety. It’s necessary for us to continue to do that through our development program and beyond, but the potential to have good safety across population of disease, non-cirrhotic patients, as well as compensated cirrhotic patients is also a potential differentiator.
And so, this is really the overall profile put in front of HCPs, even payers when we think about some of the market research that we’ve done that have highlighted some of this potential preference for an agent like seladelpar again if we’re successful through development and gaining registration. So, I think there’s a number of areas of differentiation efficacy, tolerability, as well as potentially safety that we think positions seladelpar quite well.
Lewis Stuart: I think the only thing I would add to Sujal’s comments would be really some of the market research we’ve done with the payers and being able to really describe the target product profile and to really see their response with respect to the value proposition. And I think it’s very, very clear they see a preference to seladelpar to obeticholic acid, but more importantly, I think we got really good insights around how they really see the pricing process and really that, you know this would certainly be at par at least to current pricing that we see for obeticholic acid. But more importantly, I think is the patient co-pays are going to, I think be much more supportive of them gaining access to medicine. And I think more importantly, certainly seladelpar’s product profile, combining that with in what we’ll see as we head into 2024, 2025 on both the commercial and the Medicare eligible side really provides a great opportunity to have less headwinds for patients to gain access to the medicine.
