Operator: We will take our next question from Laura Chico with Wedbush Securities. Your line is open.
Laura Chico: Good morning. Thanks very much for taking the question. Back to INGREZZA, a commercial question. I’m wondering if you can offer any comments on the duration of treatment that people are experiencing with INGREZZA, how long is staying on board. And just curious how that has been impacting, for example, the increase in guidance here? Has there been any improvements or increases in duration of treatment? And I’ll just pick one. And have you actually quantified the number of patients that were on therapy? Thank you.
Kevin Gorman: I’ll take your last question first. No, we haven’t disclosed the number of patients on therapy, though I will say that it continues to grow every quarter. And we’ve seen strong adds in terms of new patient starts, even ever since we came out of COVID lockdown environment. In terms of persistency, that’s been really strong ever since the early days of the launch, and we’ve looked at this serially going back to 2017, 2018, 2019 and someone. And what we’ve seen is that patients are staying on treatment and certainly longer than what we had expected prior to the launch and longer than what we’re seeing with persistency with our underlying psychiatric meds. The majority of these patients are on either antipsychotics, antidepressants or both.
And I think we – though we haven’t given out specific numbers for a duration of – average duration of treatment for a patient. What we’re seeing is that the persistency compares very favorably to those psychiatric meds that these patients are taking.
Laura Chico: Thanks very much.
Operator: We’ll take our next question from Sumant Kulkarni with Canaccord. Your line is open.
Sumant Kulkarni: Good morning. Thanks for taking our question. Could you remind us as to the nuance that drives the primary endpoint being glucocorticoid reduction at week 24 for adult patients, while its serum A4 in pediatric patients with glucocorticoid being a secondary endpoint at week 28. And what could this difference mean in terms of your ability to drive successful regulated discussions with pediatric and adult patients?
Kevin Gorman: So Sumant, you came in pretty mouthful. Do you mind repeating that?
Sumant Kulkarni: Sorry about that. I hope this is better. So could you remind us as to the nuance that drives the primary endpoint being glucocarticoid reduction at week 24 for adult patients, while it’s serum A4 in pediatric patients with gleucocarticoide being a secondary endpoint at week 28? And what could this difference mean in terms of your ability to drive successful regulated discussions in pediatric and adult patients?
Eiry Roberts: Thank you, Sumant. So both measures are important in the management of congenital adrenal hyperplasia in the pediatric and adult population. The function of choice of primary versus secondary end point really reflects the ability in a clinical trial setting and the kind of heterogeneity of the population in terms of the ability to demonstrate that outcome. And let me expand on that a little bit more. So from an adult perspective, obviously, androgen control is extremely important, and that is the primary mechanism of action of crinecerfont is to act on the HPA axis and reduce androgen levels. And as such, the first 4 weeks of that adult trial actually do look at androgen levels with crinecerfont treatment on a background of stable steroid dosing.
In adults, however, because you don’t have the physiologic changes that are happening to the same extent in pediatric population growth, development and things of that sort. It was possible to protocolize the steroid reduction and look at steroid dose as a primary endpoint. And that is important in the management of these patients. And we look forward very much to seeing the information there and understanding the impact of crinecerfont on that endpoint. In the pediatric setting, obviously, the primary endpoint is the 4-week androgen control, and that is extremely important as a measure in these patients since obviously, they are growing, developing and changing rapidly over time. In addition, however, we do have a real-world assessment of – a more real-world assessment of steroid reduction, which is measured out to 28 weeks.
