Oren Livnat: Thanks for taking my question. I want to focus on the upcoming KIND 1 Part A data just to build on, I guess, Annabel’s question and others before. Can you help us now with any sort of theoretical expectations around what a clinically meaningful improvement in pruritis would even look like in this population interview or based on the conversations with KOLs? I’m thinking we’ve all seen data in labels for older or more recent biologics or maybe JECs, and I’m trying to understand if the difference in this population, the characteristics, and perhaps being on top of steroids, which most, if not all, haven’t been for those other ones. What do you think we should be looking for? Because I know you’re not hard for stats, but I’m just trying to figure out what even this magnitude of price reduction from baseline is even expected this kind of population.
Chris Posner: Absolutely, let me give that to Joe, Oren.
Joana Goncalves: Thanks, Oren, it’s a great question. So first of all, I think just to highlight that our study is unique and that the patient population that we have included in KIND 1 Part A has not been investigated before in clinical studies. This is mild to moderate patients who are very itchy. It’s an itch dominant patient population. So we cannot use prior history from biological JAK studies, those are only approved for moderate to severe. So having said that, we are conducting this study to have a better understanding of what the data would look like, right, so that it can inform us for our pivotal program. Of course, our primary endpoint is looking at the 4-point Responder Analysis, which is key, but we have not powered the study to show statistical significance.
We do have internal thresholds that we will use to guide us in making an assessment. And those have been vetted by dermatologists, but key opinion leaders as well as community derms. But those are internal thresholds which will guide us. So this data is really unique data which we need to learn from to apply to our pivotal program.
Oren Livnat: So clearly this is a go, no go based on your own and your KOL’s input on what’s clinically meaningful. I guess when we think about projecting forward, is this more of a commercial hurdle, what is in fact clinically meaningful, or do you think it’s regulatory, such that if you could power this up enough to get [indescribable] on a small improvement on — relative improvement on pruritus versus TCS, is that still likely an approvable product in your mind? And just a question of you know how the commercial uptake would be or do you think there is in fact an FDA hurdle?
Chris Posner: I’ll let Joe tackle the first on the regulatory side and I’ll tackle this commercial side.
Joana Goncalves: Yeah, so from a regulatory perspective, we know what we need to do in our pivotal program, and that’s a 4-point response. We need to demonstrate that that is statistically significant from our comparator. The regulators have assessed the 4-point as what is clinically meaningful. So that’s from a regulatory perspective, and that’s what our pivotal program will demonstrate. Our first part of the program is really to provide us with the information to be able to ensure that the pivotal program is designed accordingly and powered accordingly so that we can achieve that and achieve regulatory success.
Chris Posner: Yeah, I’d say on the commercial side, where we’re very excited is the position that is both our clinical and commercial position, quite frankly, and that’s in the mild to moderate space with these patients being incredibly itchy. In fact, chronic pruritus is the most dominant feature in the mild to moderate space. Lesions aren’t necessarily their biggest concern, severe itch, and it’s chronic. What’s currently being used are topicals, namely topical steroids as Joe mentioned. They have their own limitations. Even some of the newer topical therapies have limitations on chronicity of use. So we would be the first and only oral systemic antipruritic agent in this space. So we think we’ve carved out a really significant space. That’s how our clinical program is designed. And that’s the feedback we hear on the unmet need in this space. And it’s a sizable market opportunity, and we estimated over 3 million patients. So that’s from a commercial side.
