Corcept Finishes Patient Recruitment for ALS Phase 2 Trial

Corcept Therapeutics Incorporated, a pharmaceutical company listed on NASDAQ and specializing in the development of drugs for severe endocrinologic, oncologic, metabolic, and neurologic disorders, has announced the completion of patient enrollment in the DAZALS trial. This Phase 2 trial is designed to evaluate the efficacy of dazucorilant, a selective cortisol modulator, in treating amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease that affects motor neurons and leads to muscle weakness and paralysis.

The DAZALS trial, which took place across Europe, the United States, and Canada, involved 249 participants. They were randomly assigned to receive either 150 mg, 300 mg of dazucorilant, or a placebo daily for a period of 24 weeks. The primary measure of success in this trial is the change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R), a tool used to assess motor impairment and functional decline in ALS patients. Secondary endpoints include overall survival rates and the quality of life of the participants.

Bill Guyer, Corcept’s Chief Development Officer, emphasized the urgent need for better ALS treatments. He highlighted the promising results observed in an animal model of ALS, where dazucorilant improved motor performance and reduced neuroinflammation and muscle atrophy. The full enrollment of the DAZALS trial is a significant milestone in understanding the potential of dazucorilant to enhance outcomes for individuals living with ALS. The company anticipates releasing the trial data by the end of the year.

ALS, also referred to as Lou Gehrig’s disease, is a fatal condition that affects over 25,000 individuals in the United States. It causes progressive muscle weakness, severely impacting the ability to speak, eat, move, and breathe. Elevated cortisol levels are often observed in ALS patients, particularly those with rapid disease progression. The average life expectancy post-diagnosis is two to five years.

Dazucorilant is a novel drug that selectively modulates cortisol by binding to the glucocorticoid receptor without interacting with other hormone receptors. Its ability to cross the blood-brain barrier makes it a potential candidate for treating ALS and other neurological disorders. Corcept Therapeutics holds proprietary rights to dazucorilant, which is protected by patents.

With a focus on cortisol modulation for over 25 years, Corcept Therapeutics has discovered over 1,000 proprietary selective cortisol modulators. The company is conducting advanced clinical trials for conditions such as hypercortisolism, solid tumors, ALS, and liver disease (NASH). In 2012, Corcept introduced Korlym, the first FDA-approved medication for the treatment of Cushing’s syndrome. The company is based in Menlo Park, California.