Scott Harris: Yes, well, we’ll have information on the discontinuation rates. I don’t anticipate that we’d be talking about other people’s data on that readout, but we should have that information for you in both trials.
Mayank Mamtani: And your expectation for that rate to be in what range?
Scott Harris: Yes, so historically in obesity trials, up until the recent couple of years, the discontinuation rates were quite high. We’ve seen them come down recently in that 20% to 30% range. The other thing to comment on is the fact that discontinuations in any trial like this are not a continuous process. They’re probably going to be front end loaded, so that has to be taken into consideration when you look at the discontinuations that are reported at the 24-week readout. We’ll have that information and we’ll share it with you, and we’re happy with what we’re seeing so far.
Mayank Mamtani: Great. Finally, sort of a big picture question, as you prepare for that end of Phase II FDA meeting, I know it’s a bit early to talk about that, but just curious if you are thinking of a late stage program in terms of scale that kind of mirrors what we have seen with program, which includes an active competitor arm, and/or studying pemv with certain combination regimens. Are you able to share any initial thoughts on that?
Scott Harris: Well, we haven’t had that discussion with FDA yet. Obviously, we would have an end of Phase II meeting with FDA to discuss the Phase III program. Everyone is aware of the Phase III programs that were conducted with semaglutide, and that is being conducted now with tirzepatide and obesity. It’s not just been a question of the number of trials but the number of subjects that you need to have in your safety database in order to file for approval, and typically companies have fulfilled those requirements of the safety database by doing pivotal trials. In both of those programs, there have been four pivotal trials. None of those trials of those pivotals that were filed for approval have included an active comparator.
There was a trial that was done in obesity for tirzepatide where they compared it to an outdated dose of semaglutide, Ozempic for the treatment of obesity, so I think at this point in time, the questions are there. We have a concept that would look somewhat like the other programs, but we need to have that discussion with the agency.
Mayank Mamtani: Great, thanks for taking our questions.
Operator: Thank you. One moment for our next question. Our next question comes from the line of Jon Wolleben from JMP Securities.
Jon Wolleben: Hey, good morning, and thanks for taking the question. You touched on this a little bit, about the serum lipid data that you’re going to release as well, and I was just wondering if you could give us a little more context on what you consider to be a meaningful reduction when we’re looking across the class for both 24 and 48 weeks, and how important do you think that attribute is moving forward for pemv’s ultimate utilization.
Scott Harris: Thanks Jon. Ultimately the lipid reduction we want to get is going to be at 48 weeks. There’s probably going to be progressive improvement over the course of time, so with the other programs, like tirzepatide and semaglutide, the reduction in total LDL cholesterol has been minimal. My recollection is for LDL in the range of about 3%, maybe as high as 5%. Though these drugs don’t really move cholesterol, they do have very potent effects on triglycerides. We’ve seen with the glucagon mechanism that you can move LDL cholesterol – we saw that in our first trial, so we would hope to achieve something above that 5% range, hypothetically maybe in that 10% range would be very nice to see, but again the number would have to be achieved at 48 weeks, and our first-in-human trial we were able to see a 20%, approximately 20% reduction in LDL and total cholesterol, and that’s directly attributable to the glucagon.
