Sujal Shah: And then, Ed, you asked also a question around differentiation, I think relative to Elafibranor, which is in a Phase 3 study for patients with PBC, as well currently. A couple of things to highlight here. As we’ve talked already about our program as being quite robust, over a thousand patients screened in our clinical studies, our expectation by the time we would look to potentially register seladelpar would be to have north of 600 unique patient exposures. So, we’re quite confident in the profile of seladelpar to date. We look to response to really confirm the profile that we’ve seen in a significant proportion of patients to date, all based on the things that I’ve already described. Elafibranor is a mixed PPAR alpha delta in Phase 3 for PBC, a Phase 2 study that enrolled 45 patients out to 12-weeks of treatment.
15 patients at the 80 milligram dose that they’re studying in their Phase 3 trial. So, a very relatively limited data set versus what we’ve generated for seladelpar to date. What we’ve seen at least even in that data set is comparable alkaline phosphatase lowering, but we think there’s certainly a potential for seladelpar to differentiate on its anti-inflammatory effects, potentially differentiate on its anti-pruritic effects, as well as potentially safety. I think those three things very hard to generate any, sort of a conclusion based on the small Phase 2 study conducted with Elafibranor to date. We’ll have to look to their Phase 3 study in order to make a better comparison of those. But we certainly believe that seladelpar is uniquely situated as a potent selective PPAR delta agonist, a mechanism that may very well carry significant advantages versus the mixed PPAR alpha delta of Genfit’s elafibranor.
Ed Arce: Great. That’s very helpful. Thank you so much.
Operator: And the next question comes from the line of Jay Olson with Oppenheimer. Please proceed with your question.
Jay Olson: Hi, thanks for taking the question. Congrats on the deal with Kaken. Can you please describe the market opportunity for seladelpar in Japan in terms of the patient numbers and reimbursement dynamics? And then if you could please also talk about the search criteria you used to identify Kaken as an ideal partner? And then lastly, do you have any plans to pursue other ex-U.S. partnerships besides Japan? Thank you.
Sujal Shah: Thanks for the questions Jay. I’m going to start with second part of your first question and then turn it to Lewis to talk specifically about patient numbers in Japan and the potential opportunity there. And then I’ll come back and end it with how we’re thinking about other geographic licensing opportunities. First of all, in terms of our search criteria, we’re looking for a number of things. First of all, partner that shares in our enthusiasm around the potential for seladelpar to really accelerate patient care in PBC. Again, on the heels of, all of the specific characteristics we’ve been talking about today, having a partner obviously with experience in commercializing in specific geographies, in this case Japan, and really a history of advancing care for patients and being focused on quality of life for patients.
I think these are some of the core things that Kaken represents. And as I mentioned, we couldn’t have found a better partner that shares our enthusiasm for this opportunity. And in Japan, a country in which there are no second line treatment alternatives, we believe Kaken again as we do believes that there is a significant opportunity clearly here for seladelpar. So, making sure we have the right partner with the right experience and the right enthusiasm is one. And then of course, a partner that’s aligned with how we think about the potential economic benefits of seladelpar. Obviously things like patient access are critically important to us. The differentiation that seladelpar may offer patients in other geographies as well. It’s quite important and how those things tie to economics that then allow us to redistribute some of the capital.
