Corcept Announces Results From Phase 2 Study of Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (ALS)
11 Dicembre 2024 - 10:05PM
Business Wire
Corcept Therapeutics Incorporated (NASDAQ: CORT), a
commercial-stage company engaged in the discovery and development
of medications to treat severe endocrinologic, oncologic,
metabolic, and neurologic disorders by modulating the effects of
the hormone cortisol, today announced results from the DAZALS
study, a randomized, double-blind, placebo-controlled, Phase 2
trial evaluating two doses (150 mg and 300 mg) of its proprietary
selective cortisol modulator dazucorilant in patients with ALS.
Upon completion of the trial, patients were eligible to enter an
open-label, long-term extension study, in which they received 300
mg of dazucorilant.
DAZALS did not meet its primary endpoint, which was the change
from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R)
in patients who received dazucorilant compared to those who
received placebo. Patients who received dazucorilant experienced
substantially more gastrointestinal upset at the onset of treatment
than those who received placebo. During the 24-week study, no
deaths (0/83) were observed in the 300 mg arm, compared to 5 deaths
(5/82) in the placebo group (p-value: 0.02). The open-label,
long-term extension study will continue and overall survival will
be assessed in March 2025 after all patients have had one year pass
since the onset of treatment. Dazucorilant has been granted Fast
Track Designation by the U.S. Food and Drug Administration.
Complete results from the DAZALS study will be presented at a
medical conference next year.
About the DAZALS Study
DAZALS enrolled 249 patients, randomized 1:1:1 to receive either
150 mg of dazucorilant, 300 mg of dazucorilant or placebo daily for
24 weeks. The study’s primary endpoint was to slow the decline in
motor skills and other functional criteria, compared to placebo, as
measured by the ALSFRS-R. Key secondary endpoints include overall
survival and quality of life. Patients were provided the
opportunity to receive 300mg of dazucorilant for 132 weeks in the
open-label, long-term extension of the DAZALS study. DAZALS is
being conducted at sites in Europe, the United States and
Canada.
About Amyotrophic Lateral Sclerosis (ALS)
ALS, also known as Lou Gehrig’s disease, is a fatal degenerative
neurologic disorder that affects more than 55,000 people in the
United States and Europe. ALS causes muscles to weaken and, as the
disease progresses, severely impairs patients’ ability to speak,
eat, move and breathe. There is increasing evidence that patients
with ALS, particularly those with rapid disease progression,
exhibit elevated or abnormal cortisol levels. A patient’s life
expectancy after diagnosis is two to five years.
About Dazucorilant
Dazucorilant is a selective cortisol modulator that binds to the
glucocorticoid receptor but does not bind to the body’s other
hormone receptors. Corcept is studying it as a potential treatment
for ALS and other neurologic disorders. Dazucorilant is proprietary
to Corcept and is protected by composition of matter, method of use
and other patents.
About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and
its potential to treat patients with a wide variety of serious
disorders has led to the discovery of more than 1,000 proprietary
selective cortisol modulators. Corcept is conducting advanced
clinical trials in patients with hypercortisolism, solid tumors,
ALS and liver disease. In February 2012, the company introduced
Korlym®, the first medication approved by the U.S. Food and Drug
Administration for the treatment of patients with endogenous
hypercortisolism. Corcept is headquartered in Redwood City,
California. For more information, visit Corcept.com.
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, which 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 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
patients with ALS, including the pace, conduct, timing and outcome
of DAZALS and its associated long-term extension study, as well as
oversight or requirements that may be imposed by the FDA or other
regulatory authorities. We disclaim any intention or duty to update
forward-looking statements made in this press release.
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