Corcept Therapeutics Initiates Phase 3 Trial of Relacorilant Plus Nab-Paclitaxel in Patients with Metastatic Pancreatic Cancer
Corcept Therapeutics (NASDAQ: CORT) has commenced the RELIANT trial, an open-label, Phase 3 study evaluating relacorilant in combination with nab-paclitaxel for treating metastatic pancreatic cancer. The trial aims to enroll 80 patients, with the primary endpoint being objective response rate. Interim data will be analyzed after the first 40 patients are enrolled. This follows encouraging results from a Phase 1/2 study presented at ASCO last year, indicating potential for accelerated approval if results are positive.
- Commencement of RELIANT trial for relacorilant in combination with nab-paclitaxel.
- Encouraging results from the previous Phase 1/2 study presented at ASCO.
- Potential for accelerated approval based on positive trial outcomes.
- None.
MENLO PARK, Calif., June 30, 2020 (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 RELIANT, an open-label, Phase 3 trial of relacorilant in combination with nab-paclitaxel (Celgene’s medication, Abraxane®) in patients with metastatic pancreatic cancer.
“Metastatic pancreatic cancer is an aggressive disease and there is an urgent need for effective therapies,” said Andreas Grauer, MD, Corcept’s Chief Medical Officer. “Cortisol activity suppresses apoptosis. Relacorilant reverses this effect and may enable chemotherapeutic agents such as nab-palitaxel to achieve their full, cancer-killing effect. The results of our open-label, Phase 1/2 study, which we presented at ASCO last year, were very encouraging.1 We are excited to have begun this larger, more definitive trial. We believe sufficiently positive results would support accelerated approval.”
RELIANT has a planned enrollment of 80 patients with metastatic pancreatic cancer, with an interim analysis of data from the first 40 patients. Each patient will receive relacorilant plus nab-paclitaxel. The primary endpoint is objective response rate. Secondary endpoints include progression-free survival and duration of response. RELIANT will be conducted at 20 sites in the United States.2
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.
Abraxane® is a registered trademark of Abraxis BioScience, LLC.
CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
cjames@corcept.com
www.corcept.com
1 See our ASCO poster at the Investors/Past Events tab of our website.
2 See Clinicaltrials.gov (trial identifier: NCT04329949)
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