And then there’ll be a variety of signs and symptoms everything from all of the different staining using either fluorescein or Lissamine green that we’re using or the various symptom endpoints, ocular pain, dryness, stinging, burning all those types of standard types of things that are evaluated in dry eye studies. So we will try to be as transparent as we can be. The only caveat I will put there is reasonable to assume on a positive study that we may be involved in certain discussions and maybe as part of that we may not want to disclose certain things, but otherwise we’ll try to be as transparent as we can.
Unidentified Analyst: Okay. Great. And then on Vyleesi so on out licensing of the sale in the U.S., how confident are you that you can complete this maybe by this spring?
Carl Spana: Well. When we were three consecutive quarters of double-digit growth, we were pretty confident at seven. That confidence has just enhanced and expanded. We don’t anticipate, well, we actually, we do anticipate eight consecutive quarters of double-digit growth, but we are advancing discussions and we’re reasonably confident that we will transact on Vyleesi in the very near future.
Unidentified Analyst: All right. And then one more follow-up on the GLP-1 program. Could you give us any feedback on the trial design? And in particular, are you looking for any particular type of obese patients to target, such as like those who have a minimum BMI or who are refractory to GLPs?
Carl Spana: Sure. So these are patients that will already be on GLP treatment and most likely tirzepatide. So which is a mixed GLP GIP [ph]. You’re looking for BMI probably in excess of 35. So these are going to be pretty obese patients. We’ll – we certainly will genetically profile the patients, so we’ll get a full understanding of any mutations they have in the [indiscernible] pathways as well. But we’re not stratifying on that. We’re really looking for more general obesity. I think one of the things that we really are looking for is merely the transition of melanocortin now from more specialized treatment to specific populations which genetic mutation into the more general obese population. And so this is really just the first look at really confirming the interaction between the two because I think it will be important to have for the GLP-1s to really reach their maximum potential, right?
And not that Lilly or Novo need any help from Palatin. But to really for them to reach their maximum potential, you’re going to have to add them, you’re going to have to add other mechanisms to them because not every patient can tolerate. You can’t move, not every patient can move up in the dosing for those treatments. And if you talk to a lot of patients, the side effects that deadening some of the pleasure of not just food intake, but other things that people do or can be troublesome and a lot of patients do experience the GI side effects. And so being able to minimize those and keep people on so that they really do lose the weight that they need to lose is going to be key.
Unidentified Analyst: Okay. I’m going to ask one more and then I’ll hop back in the queue. With regards to bremelanotide in the BREAKOUT study, is the primary goal to out license this as well? Or do you see yourself developing it?
Carl Spana: Well, there were two objectives. One was to look, we believe that as from autoimmune anti-inflammatory type of diseases that melanocortin system will play – have play a key role there. So this is one to show how broad it can be. So that’s we have a UC study, we have kidneys, you have the ocular studies that are going on. And it’s also to support out-licensing. I don’t see us necessarily moving forward as a kidney company. It’s really to support out-licensing or continued use. Keep in mind though, behind bremelanotide in any of our programs, we have an extensive portfolio of selective compounds for the various melanocortin receptors. So this is we’re using bremelanotide in many cases such as potentially for obesity and kidney studies, for example, as a proof of concept, proof of mechanism.
And then if there are opportunities for bremelanotide itself, great, we’ll try to pursue those or bring in third parties to help us. If not it does provide the evidentiary basis for earlier compounds to move into development and also be part of collaborations with larger companies. And we’re seeing that in other indications where we’ve gotten previous data and now the fact that we have novel compounds with is attracting larger companies.
Unidentified Analyst: Okay, great. I’m going to hop back in the queue. Thank you.
Operator: [Operator Instructions] You do have a follow-up question coming from Michael Higgins.
Unidentified Analyst: Hey.
Carl Spana: It’s okay.
Unidentified Analyst: PL8177 in ulcerative colitis, are you seeing the data in real time? And if so, any feedback for us?
Carl Spana: Well, there’s a blinded study. It’s not an open-label study. So I don’t like to really speak out to school on it. Let’s just say we are optimistic that there will be a signal. Let’s leave it just that.
Unidentified Analyst: Okay. All right. And then last one from me with regards to the erectile dysfunction study, can you share with us your regulatory plan for this combination? Like how many patients in Phase 2 and Phase 3, and then any specific regarding the number of refractory attempts with a single PDE-5…
Carl Spana: Sure. So in general, we would stick with general guidance on that. So you’d like to see that the patient to be a PDE-5 inhibitor failure should be on a maximum dose of the PDE-5 inhibitor with correct instructions. And then would have a – we would probably use the international index erectile function – the erectile function subdomain score. So we would look at – we would characterize them based on the cutoff on that domain. I’m blanking on the exact numbers, but they’re established and well published. But you’ve hit on a key thing. One of the things that we will as a regulatory process, we – as we advance from a – of a – from a study that we’re doing now to more of a formal registration study.
We will have to reach final consensus with the agency on the exact definition of a failure. But that should be pretty easy to do, as I said based on guidance that’s already out there, publications that are already out there using the international index erectile function and making sure that patients have been on a maximal dose with appropriate education.
