Corcept Therapeutics Incorporated (NASDAQ:CORT) Q3 2023 Earnings Call Transcript

Matthew Kaplan: So, first off, congrats on a strong quarter. Just wanted to focus a little bit on your pipeline. Obviously, 2024, it’s going to be a significant year for you guys with a lot of data readouts. And just in terms of the near-term readouts. Can you give us a little bit more color on the Grace study and what you’re looking to show there, primary endpoint and I guess the results should be potentially available in the first quarter given your desire to file an NDA in the second quarter.

Joseph Belanoff : I want to reintroduce the group to Bill Guyer. Bill runs all of our development programs, and he can answer your specific question.

William Guyer: So, let me remind you, the GRACE trial is an ongoing study with two parts. It’s basically two studies in one. The first part is the open label part of the study where we’re evaluating escalation of dosing from a 100 milligrams up to the maximum dose of 400 milligrams. And for those who meet response criteria for diabetes and or hypertension, both, then get into the randomized withdrawal study, which is our primary endpoint of that study. We’re going to share, as you put it top-line results and overall results when there is material information within that first half of the year as we progress towards our NDA. When you think of a success, the success for this program would be treating patients with Cushing’s syndrome exchange their Cushing’s syndrome improved dramatically.

And then we’re really treating very sick patients with Cushing’s syndrome in the BRACE trial. And relacorilant is a key in that treatment because it modifies the underlying disease of Cushing’s syndrome. A success when you look at the primary endpoint would be to evaluate those patients who respond to relacorilant. And when they go into the randomized withdrawal part, they get switched to either staying on relacorilant or switching to placebo. And so, we’re evaluating the maintenance of their response to hypertension and or diabetes control or losing that response. And that’s what we’re going to be evaluating.

Matthew Kaplan: And then, if you could, a little bit more color in terms of the data that you’re expecting from the first part of the study where you’re taking a look at the catalyst in terms of the prevalence. What should we be expecting as you announce the prevalence results in the first quarter?

William Guyer: Sure. Thank you for that second question. The goal for the catalyst trial is pretty simple. It’s to replicate and confirm the research from the past 15 years some publications of cohort studies showing the patients with difficult to control diabetes, will have a positive dexamethasone, dexamethasone suppression test or what we call a DST fee with a prevalence in the range of approximately 10% to 20%. And so right now, we’re well within that range for the Catalyst study. We look to complete that study by the end of this quarter, and publicize that within the first quarter next year.

Matthew Kaplan: And I’ll jump back in the queue now. Thanks.

Operator: Our next question comes from Roanna Ruiz with Leerink. Your line is open.

Roanna Ruiz: So, first question, curious if you could update us about, remind us about your IP expectations for Korlym and relacorilant and endogenous Cushing’s. I was just curious if there are any implications that we should think about with the recent developments with your litigation with Teva there?

Joseph Belanoff : Yes. I’m going to pass it back to Charlie Robb who is responsible for all of our legal issues.