Scot Roberts: The other thing I would add is, this preservation of lean mass has important implications for continued weight loss and for maintaining the weight loss because I think everybody appreciates that because of the sheer amount of muscle that people have, it represents the lion’s share of where calories are spent. So by maintaining more lean mass, more muscle, we maintain more of an engine to burn those calories and to reduce weight.
Operator: Our next question comes from Liisa Bayko with Evercore.
Liisa Bayko : I think most of my questions have been answered, but maybe if you could give us a little more, I guess, color on some of the kind of feedback you’re getting from potential partners as it relates to dose and Phase III strategy? And I just wanted to confirm that your plan is to wait for a partner before proceeding into Phase III for obesity?
Vipin Garg: Yes, Liisa. I mean as you can imagine, partners are looking to differentiate going forward. I mean, if you are a third or fourth or fifth company launching a drug in the obesity space, the idea of having yet another GLP-1 or even a GLP-1/GIP without differentiation, it’s going to be difficult. So therefore, we believe having the mechanism adding addition of the glucagon mechanism is very attractive, particularly to new players getting into the obesity space because, again, differentiation is going to be the key to commercially to successfully launch a product in obesity space going forward. So we are really very encouraged by the fact that, that’s what partners are focusing on. Scott talked about the quality of weight loss.
That has become a very important component of our conversations because, again, if you’re looking longer term, the conversation is now going to shift from just losing weight initially for whatever, 48 to 72 weeks. So how do you maintain that weight loss? And what is the maintenance schedule and what’s the quality of weight loss at that point? So I think on both of those fronts, we bring a very differentiated approach or a very differentiated product. So we are very encouraged by those discussions, particularly by the fact that the partners are actually getting it and focusing on it.
Liisa Bayko : How are they thinking about your titration schedule? I know you’re only doing that for the highest dose or the lower doses you have. Is there any interest in the low dose? Like what is the thinking on kind of your dosing approach? And how much of a differentiating feature is no dose titration? Or might you actually consider dose titrating to even improve tolerability more?
Vipin Garg: Yes, it’s actually a very important feature, particularly the fact that all 3 doses that we are talking about 1.2, 1.8 and 2.4, they’re all active doses, even at 1.2 milligram, some of our patients are losing 20% or more of their body weight and many patients are losing 10% or more. So 1.2 milligram is a very active dose for many patients out there. The idea is that we can have 3 doses. It will take 3 doses forward in Phase III, have approval for all 3 of them. And for doctors then, they can have the option, they can stop their patients at the lowest dose at 1.2. And by the way, the tolerability there is just like placebo at 1.2 milligrams. So really no dose titration required. They can start with that dose, see how much weight this patient is losing, and then if they need to lose more weight, they can go to 1.8 and eventually to even 2.4. So that’s really — people are really appreciating that differentiation because that simplifies the whole dosing schedule, particularly as this market moves into primary care, doctors don’t want to have to deal with dose titration.
But that’s — it’s a very important differentiating feature of pemvidutide. Scott?
Scott Harris: Yes. Ease of prescription is extremely important. Physicians don’t have the time to monitor patients through titration to give it to physician extenders or to hire them, to spend money on that. And also with each escalation, many times, you have to get approval from insurance companies to escalate. And in all of these titration schemes with other drugs, you’re starting in drugs that are not on approved or effective — which are not approved or necessarily effective doses. Patients here would start in the 1.2 milligram dose, Liisa, and that’s an active dose, and that will be an approved dose, which has a tolerability similar to placebo. And I think for primary care, to have a mean of 10% weight loss in the 48 weeks and longer with longer therapy with all the benefits is a real win, but we also offer the option of going to higher doses in patients who want to lose more weight.
Operator: Our next question comes from Corinne Jenkins with Goldman Sachs.
Corinne Jenkins : I guess maybe, the partnership has obviously been a huge focus. But as you think about timelines or kind of goals for the management team, I guess, is there anything you can share with respect to when you’d hope to have something established? And then maybe you could comment, too, on whether you’d like to have something in place by the time you get to Phase III conversations with the FDA later this year? And the other question that we had was just, how many patients were included in the body composition analysis? And is that something you’ve looked at in or are just curious how many patients and how robust that data set is?
Scott Harris: Yes. Corinne, 106 subjects participated in the study, and we have baseline week 48 data on 70 patients. And we’ve looked at the data, its statistical significance is extremely high. So we really feel that this is quality data and we look forward to presenting it in greater detail at a scientific meeting later this year.
