Corcept Therapeutics Initiates Phase 1b Trial of Relacorilant Plus Pembrolizumab (Keytruda®) in Patients with Adrenal Cancer with Cortisol Excess
Corcept Therapeutics (NASDAQ: CORT) announced the enrollment of the first patient in a Phase 1b trial of relacorilant combined with pembrolizumab for patients with adrenal cancer and cortisol excess. The trial, involving 20 patients at five sites in the U.S., aims to assess whether relacorilant can enhance the effectiveness of pembrolizumab by reducing cortisol-induced immunosuppression. Relacorilant, a selective glucocorticoid receptor modulator, is also being studied for Cushing's syndrome and various cancers.
- Enrollment of first patient in Phase 1b trial indicates progress in clinical development.
- Trial explores potential of combining relacorilant with pembrolizumab to enhance treatment efficacy.
- Relacorilant is protected by patents and has orphan drug designation for Cushing's syndrome.
- Dependence on successful trial outcomes; negative results could adversely impact market perception.
- Clinical trials face inherent risks related to design, timing, and regulatory approvals.
MENLO PARK, Calif., March 15, 2021 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of the first patient in the Phase 1b trial of relacorilant in combination with the PD-1 checkpoint inhibitor pembrolizumab (Merck’s medication, Keytruda®) in patients with adrenal cancer with cortisol excess.
“Cortisol activity blunts the cancer-killing attributes of immunotherapeutic agents such as checkpoint inhibitors,” said Andreas Grauer, MD, Corcept’s Chief Medical Officer, “which may be why pembrolizumab is rarely effective as monotherapy in patients with adrenal cancer with cortisol excess. Our trial will examine whether adding relacorilant to pembrolizumab therapy will reduce cortisol-activated immune suppression sufficiently to help pembrolizumab achieve its intended tumor-killing effect, while relacorilant treats the Cushing’s syndrome caused by excess cortisol activity.”
The open-label, Phase 1b trial has a planned enrollment of 20 patients with metastatic or unresectable adrenal cancer with cortisol excess at five sites in the United States.
About Relacorilant
Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including Cushing’s syndrome and adrenal, ovarian and pancreatic cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. Relacorilant has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.
About Corcept Therapeutics
Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing’s syndrome. Corcept has discovered a large portfolio of proprietary compounds, including relacorilant, that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.
Forward Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, the progress, enrollment, timing, design and results of our clinical trials; our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic; the availability of competing treatments; risks related to the development of relacorilant as a product candidate for adrenal cancer with cortisol excess, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; and the scope and protective power of our intellectual property. In this press release, forward-looking statements include those concerning the clinical attributes of relacorilant and its effects in patients with adrenal cancer. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website. We disclaim any intention or duty to update forward-looking statements made in this press release.
Keytruda® is a registered trademark of Merck & Co, Inc.
CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
cjames@corcept.com
www.corcept.com
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