Unidentified Analyst: Hi there. This is Mary Dryden on for Greg. Thank you so much for taking our questions. I guess in terms of the REZPEG program, how are discussions going with regulators regarding the development of REZPEG in atopic dermatitis? Maybe just looking at the program as a whole here, what other indications beyond AD and lupus do you think would benefit from this treatment? Thank you.
Howard Robin: Okay. Those are good questions. I will turn that over to JZ to give you a good answer.
Jonathan Zalevsky: Yes. Thanks Howard. Yes. Thank you for the question. So, the agency, of course has seen the totality of all of the studies that have been put forward so far. And that includes the Phase 1b study in atopic dermatitis or of course, there was feedback on the protocol and multiple discussions with the FDA on that study. In terms of the Phase 2b study, as I mentioned earlier, so we are finalizing that study protocol. And we will be seeking health authority feedback on that protocol very, very soon. So, then we will get that additional kind of information that will allow us to finalize the protocol and start the study later this year. In terms of the scope of indications, so far, REZPEG has been evaluated in a number of indications.
There was activity that we have seen in atopic dermatitis, as we discussed. There was activity in a Phase 1b study in psoriasis. We saw clinical activity in lupus. In ulcerative colitis, the study was started early, so it was not efficacious in that indication. But one of the things that gives us insight in is a range of different kind of immunological settings where we know Tregs are important, and we know that either Treg dysfunction or the absence of a Treg compartment controlling conventional or effector T-cells is a challenge. So, there are a range of additional indications that we are thinking about. There is a number in the Th2 spectrum of diseases. Obviously, atopic dermatitis is a topic here. There are multiple other atopic conditions of other organs that are definitely something that we are thinking a lot about.
There are some neuroinflammatory diseases that we think about as well and others. And so there is definitely a very wide spectrum, both biologically and with this novel mechanism, to consider multiple indications. As we reiterated on the call, and as Howard just mentioned, focus is critically important. So, besides focusing on our immunology pipeline, we are prioritizing our Phase 2b study in atopic dermatitis. But as we move forward that study and as there is data from that study, we expect that in the future we will be expanding the program as well.
Unidentified Analyst: Alright. Thank you so much.
Operator: And our next question will come from Daina Graybosch from SVB Securities. Your line is open.
Daina Graybosch: Hi. Thank you for the question. I would like to understand how you are thinking about the therapeutic window for REZPEG. Specifically, in the lupus study, you also had a dose response in tolerability or safety. And the highest dose, I think is close to the dose where you saw the greatest Treg increases and efficacy in AtD and seem pretty intolerable in lupus. So, how are you navigating that in your Phase 2b? Thank you.
Howard Robin: Well, I will turn that over to JZ for a more thorough explanation, but the effects of these – of a Treg mechanism is somewhat different in different diseases. And JZ, do you want to comment further on that?
