REDWOOD CITY, Calif. – Corcept Therapeutics (NASDAQ:CORT) Incorporated (NASDAQ: CORT), a company specializing in the development of drugs to treat severe disorders by targeting cortisol effects, reported that its Phase 2 DAZALS study of dazucorilant did not meet its primary endpoint for patients with ALS (Amyotrophic Lateral Sclerosis), also known as Lou Gehrig’s disease. The results were from a randomized, double-blind, placebo-controlled trial.
The primary endpoint was the change in the ALS Functional Rating Scale-Revised (ALSFRS-R), which measures motor function decline. Patients treated with dazucorilant did not show a statistically significant difference compared to those receiving a placebo. However, the study found that during the 24-week period, no deaths occurred in the group receiving the higher 300 mg dose of dazucorilant, while five deaths were reported in the placebo group.
Despite the primary endpoint not being met, the trial's survival data has prompted Corcept to continue with an open-label extension study, where all participants can receive the 300 mg dose. This extension is set to assess overall survival in March 2025, after each patient has completed one year of treatment.
Dazucorilant has received Fast Track Designation from the U.S. Food and Drug Administration, which is reserved for drugs that treat serious conditions and fill an unmet medical need. Corcept's focus on cortisol modulation has led to the discovery of over a thousand proprietary selective cortisol modulators, with dazucorilant being investigated as a potential treatment for ALS and other neurological disorders.
ALS is a fatal, degenerative neurological disorder affecting over 55,000 individuals in the United States and Europe. It severely impairs physical functions, and life expectancy post-diagnosis is typically two to five years. Elevated or abnormal cortisol levels have been observed in patients with ALS, particularly those with rapid disease progression.
The full results from the DAZALS study are expected to be presented at a medical conference next year. The study enrolled 249 patients across sites in Europe, the United States, and Canada, and was designed to evaluate the efficacy of dazucorilant in slowing the decline in motor skills and other functional abilities.
This article is based on a press release statement from Corcept Therapeutics. The company has been conducting advanced clinical trials in several severe disorders, including hypercortisolism, solid tumors, and liver disease, since launching its first FDA-approved medication for endogenous hypercortisolism in 2012. InvestingPro analysis reveals the company's strong financial health with a "GREAT" overall score, maintaining minimal debt and a healthy current ratio of 3.7. For detailed insights and 16 additional ProTips about CORT, investors can access the comprehensive Pro Research Report available on InvestingPro.
In other recent news, Corcept Therapeutics displayed a significant increase in third-quarter revenue, reaching $182.5 million, marking a 48% year-over-year rise. The company also reported a net income of $47.2 million for the third quarter. These recent developments led the company to raise its full-year revenue guidance for 2024 to between $675 million and $700 million.
In addition to its financial growth, Corcept Therapeutics is making strides in its drug pipeline. The company is planning to submit a New Drug Application for relacorilant, a treatment for Cushing's syndrome, by the end of the year. This submission is backed by positive results from the GRACE and GRADIENT studies.
However, the company is currently involved in litigation with Teva Pharmaceuticals over a generic version of Korlym. Despite this, Corcept Therapeutics remains optimistic about its trajectory, aiming to become a $3 billion business in the next five years. The company anticipates significant data from the CATALYST Phase 4 trial and ROSELLA study by year-end, which could potentially transform treatment landscapes.
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