Corcept attributes its revenue boost to better recognition of Cushing’s

Q3 returns reflect investment in helping physicians treat hypercortisolism

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Corcept Therapeutics is expecting to earn nearly $500 million in revenue this year, which is due in large part to the increased recognition of Cushing’s syndrome, the company noted in a recent corporate update.

Corcept, which markets Korlym (mifepristone) — a therapy approved to control high blood sugar in certain adults with Cushing’s syndrome who have glucose intolerance or type 2 diabetes — reported $123.6 million in total revenue in this year’s third financial quarter. This number is a 22% increase compared with the company’s third quarter earnings last year.

“Our strong results in the third quarter reflect returns on our substantial investment in helping physicians to better recognize and treat hypercortisolism,” Joseph Belanoff, MD, CEO of Corcept, said in a company press release. “As screening for hypercortisolism (Cushing’s syndrome) becomes more common, the number of patients receiving medical therapy grows.”

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“We are confident this trend will continue,” Belanoff said. “Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it.”

Cushing’s syndrome comprises a group of disorders driven by hypercortisolism, or excess levels of the stress hormone cortisol, which can lead to complications like high blood pressure and dysregulated blood sugar. Cushing’s disease is a specific form of the syndrome caused by a tumor in the brain’s pituitary gland.

Korlym works by binding to cortisol receptors, thereby preventing cortisol from interacting with them and reducing the effects of the hormone in the body. Corcept is also developing an experimental therapy called relacorilant that’s designed to block cortisol receptors.

“Relacorilant has tremendous promise as a treatment for patients with Cushing’s syndrome and we are eager to make it available,” said Bill Guyer, Corcept’s chief development officer.

A Phase 3 clinical trial called GRACE trial (NCT03697109) is testing relacorilant in about 130 people with Cushing’s syndrome who also have high blood pressure, diabetes, and/or impaired glucose tolerance (high blood sugar). The study finished enrolling patients a few months ago, and results are expected next year.

Assuming that findings are positive, Corcept is planning to ask the U.S. Food and Drug Administration (FDA) to approve relacorilant in the second quarter of 2024.

The company is also conducting another Phase 3 clinical trial, called GRADIENT (NCT04308590), which is testing relacorilant in people with Cushing’s syndrome caused by a cortisol-producing tumor in the adrenal glands. Recruitment is still ongoing at sites in the U.S., Europe, and Israel. Results from GRADIENT are expected in mid-2024.

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Phase 4 trial to assess prevalence of hypercortisolism in type 2 diabetes

A third two-part study being run by Corcept is the Phase 4 CATALYST trial (NCT05772169), which seeks to enroll about 1,000 people with hard-to-treat type 2 diabetes. Patients are still being recruited in the U.S. The trial’s main goal in the first part is to assess the prevalence of Cushing’s syndrome or hypercortisolism in this patient population. Results from this initial phase of CATALYST are expected in the first quarter of 2024.

Patients who have hypercortisolism will be able to enroll in a placebo-controlled treatment phase testing Korlym’s safety and efficacy in the second part of the study. Findings from this part of CATALYST are expected by the end of 2024.

“Our CATALYST trial has the potential to serve as a landmark study to guide physician’s understanding of Cushing’s syndrome. CATALYST is the largest study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes,” Guyer said.

“We expect CATALYST’s findings to greatly enhance physicians’ ability to diagnose and treat the many patients with Cushing’s syndrome whose condition now frequently goes undiagnosed. We expect data from the prevalence phase of the CATALYST study by early next year,” he added.