Corcept Therapeutics Initiates DAZALS – A Phase 2 Trial in Amyotrophic Lateral Sclerosis (ALS)

MENLO PARK, Calif., Oct. 11, 2022 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated CORT, a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, today announced that it has initiated DAZALS – a Phase 2 trial of its proprietary selective cortisol modulator dazucorilant in patients with amyotrophic lateral sclerosis (ALS).

"ALS, also known as Lou Gehrig's disease, is a devastating neuromuscular illness with an urgent need for better treatment," said Bill Guyer, PharmD, Corcept's Chief Development Officer. "We are excited to initiate this important study in collaboration with TRICALS, the leading ALS academic consortium in Europe."

"Dazucorilant showed great promise in animal models of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy," said principal investigator Dr. Leonard van den Berg, chairman of TRICALS and professor of neurology at the University Medical Center Utrecht in the Netherlands. "I am excited to partner with Corcept to study dazucorilant's potential to significantly improve treatment outcomes for people living with ALS."

DAZALS is a 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS. The primary endpoints will be ALS Functional Rating Scale-Revised (ALSFRS-R) total score and safety. Key secondary endpoints include overall survival and quality of life. Additional information about DAZALS can be found here.

About Corcept Therapeutics

Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol and owns extensive United States and foreign intellectual property covering both their composition and their use to treat a variety of serious disorders. The company is conducting clinical trials of its leading cortisol modulators as potential treatments for patients with Cushing's syndrome, ovarian and adrenal cancer, weight gain caused by the use of antipsychotic medications, liver disease and ALS. Corcept's drug Korlym® was the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing's syndrome.

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 such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business, conduct our clinical trials and achieve our other goals during the COVID-19 pandemic; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website.

In this press release, forward-looking statements include those concerning the development of dazucorilant as a treatment for ALS, including its clinical attributes, regulatory approvals, mandates and oversight, and other requirements; our DAZALS trial, including its design, results and probability of success. We disclaim any intention or duty to update forward-looking statements made in this press release.

CONTACT:
Corcept Therapeutics
Investor Relations
ir@corcept.com
www.corcept.com