Corcept Completes Enrollment in Phase 2 DAZALS Trial in Patients With Amyotrophic Lateral Sclerosis (ALS)
15 April 2024 - 2:00PM
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 completion of enrollment in DAZALS, a
randomized, double-blind, placebo-controlled Phase 2 trial of its
proprietary selective cortisol modulator dazucorilant in patients
with amyotrophic lateral sclerosis (ALS).
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 is change
from baseline in the ALS Functional Rating Scale-Revised
(ALSFRS-R), which measures motor impairment and functional
deterioration in patients with ALS. Key secondary endpoints include
overall survival and quality of life. DAZALS was conducted at sites
in Europe, United States and Canada.
“Better treatments for ALS are urgently needed,”
said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
“Dazucorilant showed great promise in an animal model of ALS –
improving motor performance and reducing neuroinflammation and
muscular atrophy. Fully enrolling DAZALS is an important step
toward understanding dazucorilant's potential for significantly
improving outcomes for people living with this devastating disease.
We expect data by the end of this year.”
About ALSALS, also known as Lou
Gehrig’s disease, is a fatal degenerative neurologic disorder that
affects more than 25,000 people in the United States. 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 exhibit elevated or
abnormal cortisol levels, particularly those with rapid disease
progression. A patient’s average life expectancy after diagnosis is
two to five years.
About DazucorilantDazucorilant
is a selective cortisol modulator that binds to the glucocorticoid
receptor (GR), but does not bind to the body’s other hormone
receptors. Dazucorilant crosses the blood-brain barrier and 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 TherapeuticsFor
over 25 years, Corcept’s focus on cortisol modulation and its
potential to treat patients across a wide variety of serious
disorders has led to the discovery of more than 1,000 proprietary
selective cortisol modulators. Corcept’s advanced clinical trials
are being conducted in patients with hypercortisolism, solid
tumors, amyotrophic lateral sclerosis (ALS) and liver disease
(NASH). 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 Cushing’s syndrome. Corcept is
headquartered in Menlo Park, California. For more information,
visit Corcept.com.
Forward-Looking
StatementsStatements 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 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: Dazucorilant, including its
clinical attributes and potential to become a treatment for
patients with ALS or any other disorder, the conduct, pace and
outcome of our DAZALS trial, and dazucorilant’s potential
commercialization. We disclaim any intention or duty to update
forward-looking statements made in this press release.
CONTACTInvestor
inquiries:ir@corcept.comMedia inquiries:communications@corcept.com
www.corcept.com
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