Ascendis Pharma A/S (NASDAQ:ASND) Q4 2022 Earnings Call Transcript

So this is why it’s also important for us to look at our Phase 3 in adult growth hormone deficiency, because the two other potential long acting where we believe there’s potential one less now but showed basic not any improvement on body composition in that Phase 3 trial. Novo Nordisk showed they can only get the half of the stake basic to daily growth hormone. And this is where we believe with our unmodified somatrope potential we will be at least as good as daily growth hormone. So we believe that our product profile is always so highly differentiated to both daily growth hormone and other long acting growth hormone that we always will provide us the clinical benefit compared to all other treatment regimes.

Operator: Our next question will be coming from Leland Gershell of Oppenheimer.

Leland Gershell: Two from me. Jan, I know you had responded earlier that you don’t expect a REMS or blackbox warning on the PTH label. But could you comment on any potential for monitoring requirements with patients on the product?

Jan Mikkelsen: Could you clarify your question, what do you mean exactly?

Leland Gershell: Well, in other words, if patients need to be monitored for serum calcium, bone biomarkers whatnot?

Jan Mikkelsen: That is an question where you will say will be provide an beta stability for this patient group than they have in the current setup where the basic are being monitored for calcium really, really, really often. And I believe you will see it in different stages. I believe when you transition over from what we call the conventional part of therapy over to TransCon PTH, I think that will be at least the same kind of monitoring, because you want to be quite sure you stabilize the patient in the right manner. When they are stable, which we see after one to two year on a PTH dose, where we see more and more stability coming in because calcium metabolic system or calcium hemostasis starting to be stabilized, I will pretend to see from a patient perspective that you will potentially need a list, what we call, monitoring of it.

I think this is where I believe that element like is not typically something you typically will analyze for any patient group in this way. What we have seen in our clinical study where now patient are for over three, four years, your basically seeing that we do normalization more and more and more of every parameter, and that is includes both bone density and is also including bone markers. So I will not expect that it will be part of a standard monitoring.

Leland Gershell: And second question from me is with respect to achondroplasia. Obviously, the primary endpoint and for regulatory purposes, it’s about type velocity. But as you had mentioned earlier, there are many other benefits that a replacement CNP could provide. Could you just sort of inform us as to which of the other benefits that maybe not captured by primary endpoint type data but would be very important, seen as most important by the community?