Corcept Therapeutics Incorporated (NASDAQ:CORT) Q4 2022 Earnings Call Transcript

But getting them back on paid insurance as they have before is, in some sense, a maneuver that occurs every year. The quicker we do that, the more it adds back to first quarter revenues. And then, once that’s in place, we’re on our ark for the rest of the year.

Dennis Ding: Got it. Thank you.

Joseph Belanoff: Sure.

Operator: Our next question is from the line of Greg Fraser with Truist. Please proceed with your question.

Greg Fraser: Good afternoon, folks. Thanks for taking the question. I got on a little late, I apologize if you covered this already. But I was hoping you could comment on the protocol for the CATALYST study and talk about the enrollment criteria, the types of patients that will be enrolled? And I’m curious about it, it seems like it’s a study that — obviously, it’s quite large and it’s unprecedented. It seems like a study that could potentially capture patients that would otherwise be started on Korlym. I know you’re — the study will be run by docs that you’re not calling on, it sounds like. But could this create a headwind for new starts on Korlym? Or am I thinking about that the wrong way?

Joseph Belanoff: Hey, Greg, just sort of sorting this out, I want to give the first part to Bill, who is conducting the study. So, Bill, can you answer the questions about protocol.

Bill Guyer: So, CATALYST is an example that I think we are showing our continued investment in our compounds whether approved or investigational. And the CATALYST, as Sean had mentioned, is the largest study of this kind. We’re going to be testing two really rigorous important points. One is to understand the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes. And the second is to understand the efficacy and safety of Korlym in these patients. And in that patient population, we’re going to be looking at 1,000 patients, in where we’re going to be simply testing them for hypercortisolism with a simple DST. And from there, we’re going to be then evaluating them for those who are positive will then be selected to and have a choice to go into the second part of the study, which is that treatment part of the study.

As Sean had also previously mentioned, we’re working with the top diabetologists. And while this is a large study, these diabetologists have thousands of patients in their practice. And have already identified many of them who could meet the inclusion and exclusion criteria of this study. And when you look at that inclusion and exclusion criteria, I’ll give you a few points there. It’s for adult patients who are aged 18 to 80; those who are difficult to control diabetes, and that’s defined simply by having a hemoglobin A1C of greater than 7.5, but less than 11.5; and are taking multiple anti-hyperglycemic drugs; plus many other things. But that’s the simple design of the trial of how to get in. We believe by working with these top diabetologists, that we’ve designed a trial that’s easy to enroll and we’re on track to start the trial this — next month in March and complete enrollment of this trial by the end of this year.

Joseph Belanoff: Second part of the question, Greg, I’m going to give you to Sean.

Sean Maduck: Yes, thank you. And the question was whether or not this study will impact potentially Korlym patients that would have been on Korlym previously. The answer to that is no. Remember, this is a group of physicians not only are they not prescribing Korlym today, they’re not even aware that these hypercortisolism patients exist in their practice. They are treating these patients for their diabetes and aren’t aware. So, again, let me go back to what I said a moment ago is just that the hope of this study is that, that will provide definitive prevalence in treatment data that will help, I’ll say, sway and motivate this group of physicians who currently aren’t treating or diagnosing.