Corcept Therapeutics Completes Enrollment in Controlled, Phase 2 Trial of Relacorilant Plus Nab-Paclitaxel in Patients with Metastatic Ovarian Cancer

Rhea-AI Summary

Corcept Therapeutics (NASDAQ: CORT) has completed patient enrollment in its Phase 2 trial of relacorilant combined with nab-paclitaxel for treating metastatic, platinum-resistant ovarian cancer. A total of 177 patients were enrolled across 28 sites in North America and Europe. The primary endpoint focuses on progression-free survival, alongside secondary measures like objective response rates. Following promising Phase 1/2 results, data from this trial are expected in the first half of the next year, positioning Corcept for potential advancements in its clinical portfolio.

Positive

• Successfully completed enrollment of 177 patients in the Phase 2 trial.
• Promising results from previous Phase 1/2 trial support the ongoing study.
• The trial's design includes robust endpoints, enhancing data reliability.

Negative

• None.

MENLO PARK, Calif., July 23, 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 the completion of enrollment in its controlled, Phase 2 trial of relacorilant combined with nab-paclitaxel (Abraxane^®) in patients with metastatic, platinum-resistant ovarian cancer.

“We achieved this milestone thanks in part to the hard work and enthusiasm of our clinical investigators,” said Andreas Grauer, MD, Corcept’s Chief Medical Officer. “Data from our open-label, Phase 1/2 trial were very promising.¹ We expect to have results from this larger, controlled trial in the first half of next year.”

The trial has enrolled 177 patients at 28 sites in the United States, Canada and Europe. Participants were randomly assigned to receive either relacorilant in combination with nab-paclitaxel or nab-paclitaxel alone. The trial’s primary endpoint is progression free survival, with secondary endpoints including objective response rate and duration of objective response.²

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor, the receptor for cortisol which is activated when cortisol levels are high. Relacorilant does not bind to the body's other hormone receptors. Corcept is studying relacorilant as a potential treatment for a variety of serious disorders, including Cushing’s syndrome and advanced 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. Corcept’s medication 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.

¹ For more data, see our ASCO poster at the Investors/Past Events tab of our website.

² For additional information, see Clinicaltrials.gov (trial identifier: NCT03776812)

CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
cjames@corcept.com
www.corcept.com

FAQ

What is the purpose of Corcept's Phase 2 trial with relacorilant?

The trial aims to evaluate the efficacy of relacorilant combined with nab-paclitaxel in patients with metastatic, platinum-resistant ovarian cancer.

How many patients were enrolled in Corcept's Phase 2 trial?

A total of 177 patients were enrolled across 28 sites in the United States, Canada, and Europe.

When can we expect results from Corcept's Phase 2 trial?

Results from the trial are anticipated in the first half of the following year.

What are the primary and secondary endpoints of the trial?

The primary endpoint is progression-free survival, while secondary endpoints include objective response rate and duration of response.

What is relacorilant and its significance in this trial?

Relacorilant is a selective modulator of the glucocorticoid receptor, being studied for its potential in treating various serious disorders, including ovarian cancer.