About Corcept Therapeutics

Corcept Therapeutics Incorporated operates as a commercial-stage company that engages in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. The company markets Korlym in the United States for the treatment of patients suffering from hypercortisolism (Cushing’s syndrome). The company has discovered more than 1,000 proprietary cortisol modulators that bind to the GR but have no affinity for the PR and so do not cause Korlym’s PR-related side effects. The company’s lead compounds are being evaluated in clinical trials as potential treatments for a variety of serious disorders – Cushing’s syndrome, advanced ovarian cancer, adrenal cancer with cortisol excess, prostate cancer, ALS and NASH. Cushing’s Syndrome Korlym: The company sells Korlym in the United States, using experienced sales representatives to call on physicians caring for patients with Cushing’s syndrome (also called hypercortisolism). The company also has a field-based force of medical science liaisons. The company uses one specialty pharmacy and one specialty distributor to distribute Korlym and provide logistical support to physicians and patients. Relacorilant: The company is conducting two Phase 3 trials (GRACE and GRADIENT) of its proprietary, selective cortisol modulator, relacorilant, as a treatment for patients with Cushing’s syndrome. Relacorilant was well-tolerated in its Phase 1 and Phase 2 trials. Patients in the Phase 2 trial exhibited meaningful improvements in glucose control, hypertension, weight, liver function, coagulopathy, cognition, mood, insulin resistance and quality of life measures. Relacorilant shares Korlym’s affinity for the GR, but, unlike Korlym, has no affinity for the PR, and so is not the abortion pill. The company’s second Phase 3 trial of relacorilant, GRADIENT, is studying patients whose Cushing’s syndrome is caused by a benign adrenal tumor. These patients often exhibit less severe symptoms or have a more gradual course of disease than patients with other etiologies of Cushing’s syndrome, although their health outcomes are ultimately poor. Half of the patients in GRADIENT will receive relacorilant for 22 weeks and half will receive placebo. The trial’s primary endpoints are improvements in glucose metabolism and hypertension. The planned enrollment for this study is 130 patients. Oncology Relacorilant in Patients with Advanced Ovarian Cancer: In May 2021, the company announced preliminary results from its 178-patient, controlled, multi-center, Phase 2 trial of relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer. Study participants were randomized to one of three treatment arms: 60 women received 150 mg of relacorilant intermittently (the day before, the day of and the day after their weekly nab-paclitaxel infusion) and 58 women received a daily relacorilant dose of 100 mg per day in addition to nab-paclitaxel. Sixty women received nab-paclitaxel alone. In June 2022, the company initiated a pivotal Phase 3 trial (ROSELLA) that seeks to replicate the positive results observed in its Phase 2 study. ROSELLA has a planned enrollment of 360 women with recurrent, platinum-resistant ovarian cancer, half of whom will receive 150 mg of relacorilant intermittently in addition to nab-paclitaxel, with the other half receiving nab-paclitaxel monotherapy. The primary endpoint is PFS; overall survival is a key secondary endpoint. Patients in ROSELLA will have received prior bevacizumab therapy, which is the standard of care for patients with platinum-resistant ovarian cancer. Women with a history of tumors that do not respond to initial platinum-based treatments (i.e., women with primary platinum-refractory disease) and those who have received more than three prior lines of therapy will be excluded. Relacorilant in Patients with Adrenal Cancer with Cortisol Excess. The company is conducting an open-label, Phase 1b trial of relacorilant plus the PD-1 checkpoint inhibitor pembrolizumab in patients with metastatic or unresectable adrenal cancer whose tumors produce cortisol. The trial is examining whether adding relacorilant to pembrolizumab therapy reduces cortisol-activated immune suppression sufficiently to help pembrolizumab achieve its intended tumor-killing effect. Relacorilant is also expected to treat the patients’ Cushing’s syndrome generated by their tumors’ excess production of cortisol. Relacorilant in Patients with Prostate Cancer: The company’s collaborators at the University of Chicago have initiated a randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer, pre-prostatectomy. The company is providing relacorilant and placebo for the study and has licensed patents covering the use of relacorilant combined with anticancer agents such as enzalutamide in the treatment of patients with this indication. ALS The company’s selective cortisol modulator dazucorilant improved motor performance and reduced neuroinflammation and muscular atrophy in animal models of ALS. Following these compelling results, the company initiated a Phase 2 trial (DAZALS) of dazucorilant in patients with ALS in October 2022. DAZALS has a planned enrollment of 198 patients, randomized 1:1:1 to receive either 150 mg or 300 mg of dazucorilant or placebo daily for 24 weeks. Metabolic Diseases Liver Disease: The company’s Phase 1b study has identified a dosing regimen that effectively reduced liver fat, improved liver health and key metabolic and lipid measures and was well-tolerated. Following these compelling results, it initiated a Phase 2b trial (MONARCH) of miricorilant in patients with NASH in October 2023. MONARCH has a planned enrollment of 150 patients, randomized 2:1 to receive either 100 mg of miricorilant twice weekly or placebo for 48 weeks. The primary endpoint is reduction in liver fat, with NASH resolution and fibrosis improvement as key secondary endpoints. AIWG: Patients in the company’s two double-blind, placebo-controlled, Phase 2 trials (GRATITUDE and GRATITUDE II) of miricorilant with already existing weight gain stimulated by anti-psychotic medication did not exhibit weight loss. Development of Other Selective Cortisol Modulators The company’s portfolio of proprietary selective cortisol modulators consists of four structurally distinct series. The company holds U.S. and foreign patents covering compounds and their methods of use in a wide range of indications. The company continues to identify selective cortisol modulators and plans to advance the most promising of them towards the clinic. Clinical Trial Agreements The company typically conducts its clinical trials with the assistance of clinical research organizations (CROs). ICON plc is helping the company conducts its GRACE and GRADIENT trials. Syneos Health is helping it conduct its ROSELLA trial. Julius Clinical is helping it conduct its DAZALS trial. Medpace Research is helping it conducts its MONARCH trial. Research and Development Spending The company incurred $184.4 million of research and development expense in the year ended December 31, 2023. Manufacturing Korlym The company relies on contract manufacturers to produce Korlym and its product candidates. Because the company has an agreement with one third-party manufacturer to supply mifepristone, the active pharmaceutical ingredient (API) in Korlym, it has purchased and holds significant quantities of API. The company has two third-party manufacturers to produce and bottle Korlym tablets. Competition Korlym competes with Signifor (pasireotide) Injection and Isturisa (osilodrostat). Both of these drugs are approved by the FDA for the treatment of adult patients with Cushing’s disease who are not candidates for pituitary surgery or for whom surgery did not work, and both are sold by the Italian pharmaceutical company Recordati S.p.A (Recordati). Cushing’s disease is a subset of Cushing’s syndrome. In the EU, osilodrostat is also approved as a treatment for Cushing’s syndrome. Korlym also competes with Recorlev (levoketoconazole), a chiral form of the commonly-prescribed cortisol synthesis inhibitor ketoconazole, that is sold by Xeris Biopharma Holdings, Inc. (Xeris), as a treatment for patients with Cushing’s syndrome. Intellectual Property The company owns U.S. composition of matter patents related to its next-generation cortisol modulators. Foreign counterparts of some of these patents have been issued in Europe, Japan, China, Canada, Australia and other countries. The expiration dates of these patents and their foreign counterparts range from 2025 to 2041. The company also owns U.S. and foreign patents directed to the use of its selective cortisol modulators in the treatment of a variety of serious disorders, including Cushing’s syndrome, various cancers, fatty liver disease, AIWG, and other disorders. The company continues to file patent applications in the United States and abroad. Cushing’s Syndrome: The composition of matter patent covering Korlym’s active ingredient, mifepristone, has expired. The company owns U.S. method of use patents directed to the use of Korlym in the treatment of patients with Cushing’s syndrome, with expiration dates ranging from 2028 to 2038. Furthermore, the company owns U.S. compound and method of use patents using its proprietary selective cortisol modulators directed to the treatment of patients with Cushing’s syndrome, with expiration dates ranging from 2033 to 2041. The company has asserted two patents directed to patients with Cushing’s syndrome in a lawsuit against Teva Pharmaceuticals USA, Inc. (Teva) in a lawsuit filed in Federal District Court. On December 29, 2023, the Court found that Teva’s proposed generic version of Korlym would not infringe either patent. Oncology: The company owns U.S. patents covering methods of treating cancer using its proprietary selective cortisol modulators with expiration dates ranging from 2033 to 2041. In addition, the company has exclusively licensed from the University of Chicago U.S. patents for the use of cortisol modulators in the treatment of triple-negative breast cancer, and the use of cortisol modulators to treat castration resistant prostate cancer (CRPC). The company is required to pay the University of Chicago customary milestone fees and royalties on revenue from products commercialized under the issued patents or patents that may issue pursuant to the pending applications. The company’s license will end upon expiration of the licensed patents in 2031 and 2033 or upon notification by it to the University of Chicago. The company holds U.S. and international patents covering relacorilant’s composition of matter, as well as U.S. patents covering its use to treat patients with ovarian and pancreatic cancer. The company also owns or has exclusively licensed U.S. and European patents covering the use of GR modulators, including relacorilant, miricorilant, exicorilant, dazucorilant, and other of its proprietary compounds to treat a variety of disorders, including CRPC and other solid tumors. Relacorilant has been designated an orphan drug in both the United States and the EU for the treatment of pancreatic cancer. Other Indications: In addition to the United States and foreign patents the company owns or has licensed relating to Cushing’s syndrome and various cancers, it owns U.S. and foreign patents for the use of cortisol modulators to treat ALS, AIWG, fatty liver disease, delirium, catatonia, psychosis induced by interferon-alpha therapy, migraine headaches, gastroesophageal reflux disease, neurological damage in premature infants, for the improvement of therapeutic response to electroconvulsive therapy, and in the treatment of diseases using combined steroid and GR modulator therapy. The expiration dates of these patents and their foreign counterparts range from 2025 to 2039. History Corcept Therapeutics Incorporated was founded in 1998. The company was incorporated in the state of Delaware in 1998.