Corcept Submits NDA for Relacorilant for Platinum-Resistant Ovarian Cancer

Corcept Therapeutics Incorporated, a company based in Redwood City, California, has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its novel drug, relacorilant. This selective cortisol modulator is intended to treat patients with platinum-resistant ovarian cancer. The company operates in the medical field by developing treatments for severe disorders related to endocrinology, oncology, metabolism, and neurology, specifically targeting the modulation of cortisol, a stress hormone.

The NDA submission is supported by data from successful Phase 3 ROSELLA and Phase 2 clinical trials. During these studies, patients treated with a combination of relacorilant and nab-paclitaxel demonstrated better progression-free survival and overall survival rates compared to those who received only nab-paclitaxel. Notably, relacorilant was found to be well-tolerated, with adverse events in the combination treatment group showing similar type, frequency, and severity as those in the monotherapy group. This suggests that relacorilant does not add any additional safety burden to patients.

Dr. Joseph K. Belanoff, CEO of Corcept Therapeutics, expressed optimism about the submission, highlighting that the company now has two drug applications under FDA review. These include relacorilant for combination therapy in ovarian cancer and as a treatment for hypercortisolism. The company is preparing its oncology and endocrinology divisions to ensure the swift availability of relacorilant following regulatory approval.

Relacorilant operates as an oral therapy and acts as a selective glucocorticoid receptor (GR) antagonist, modulating cortisol activity by specifically binding to the GR without affecting other hormone receptors in the body. Corcept is exploring its potential not only in ovarian cancer but also in other serious conditions such as endogenous hypercortisolism and prostate cancer. The drug is proprietary to Corcept and is safeguarded by various patents. It has received orphan drug designation from both the FDA and the European Commission for the treatment of hypercortisolism, and from the European Commission for treating ovarian cancer. The FDA has set a target action date of December 30, 2025, for relacorilant as a treatment for hypercortisolism.

Cortisol is known to contribute to tumor growth through several mechanisms. It can help solid tumors resist chemotherapy by preventing cellular apoptosis, a process that chemotherapy aims to trigger in cancer cells. Additionally, in some cancers, cortisol might encourage tumor growth by activating certain oncogenes. Furthermore, cortisol suppresses the immune system, impairing the body’s natural ability to combat diseases, including cancer.

Ovarian cancer ranks as the fifth leading cause of cancer-related death among women. Patients whose cancer returns within six months after receiving platinum-based treatments are classified as having platinum-resistant disease, with limited treatment options available to them. The median survival following recurrence is about 12 months with existing chemotherapy treatments. Each year, roughly 20,000 women in the U.S. with platinum-resistant ovarian cancer are potential candidates for new therapies, with a similar number in Europe.

Corcept Therapeutics has been a pioneer in cortisol modulation for over 25 years, discovering more than 1,000 selective cortisol modulators and glucocorticoid receptor antagonists. The company is currently conducting advanced clinical trials for conditions including hypercortisolism, solid tumors, ALS, and liver disease. In 2012, Corcept introduced Korlym®, the first FDA-approved medication for endogenous hypercortisolism.