Corcept Completes Enrollment in Phase 2 DAZALS Trial in Patients With Amyotrophic Lateral Sclerosis (ALS)
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Insights
The announcement of the completion of enrollment in the Phase 2 clinical trial of dazucorilant by Corcept Therapeutics is a significant development within the pharmaceutical industry and for stakeholders, including patients, healthcare providers and investors. The focus on amyotrophic lateral sclerosis, a condition with limited treatment options, indicates a strategic interest in addressing unmet medical needs, which can lead to both social and economic implications.
The choice of the ALS Functional Rating Scale-Revised as the primary endpoint reflects a scientific commitment to measuring meaningful clinical progression of the disease. A positive outcome from this trial could not only enhance patient care but also significantly impact Corcept's market position and stock valuation, particularly if the drug demonstrates a marked improvement in motor impairment and functional deterioration relative to existing ALS treatments.
From a long-term perspective, continued investment in research and the potential approval of dazucorilant could spearhead additional revenue streams for Corcept. It also sets a precedent for therapeutics targeting neuroinflammation, a pathway that's gaining traction in the medical community.
Completion of patient enrollment is a critical milestone that often leads to increased investor confidence, as it signals progression in the drug development pipeline and starts the countdown to potential commercialization. The emphasis on the drug's promise in preclinical models, such as improving motor performance and reducing neuroinflammation, provides a narrative that could influence investor optimism.
Should the trial outcomes be positive and dazucorilant moves closer to market approval, we can anticipate possible stock price appreciation. However, investors should remain aware of the risks inherent in clinical trials, notably the chance of negative results or adverse safety findings that could adversely affect Corcept's financial health. It's also vital to monitor the competitive landscape, as other pharmaceutical companies may be working on similar drugs for ALS which could impact the market dynamics.
ALS therapy development has significant health economics implications. Effective treatments can not only improve patient outcomes but also reduce long-term healthcare costs associated with managing chronic symptoms and providing specialized care. Corcept's investment in dazucorilant's clinical trials represents a potential reduction in socioeconomic burden should the drug prove to be effective.
However, economic considerations extend beyond the scope of clinical efficacy. The pricing strategy for new drugs, particularly in specialized therapeutic areas like ALS, often faces scrutiny. The balance between recouping research and development investments and ensuring patient access is delicate. Consequently, the financial impact of a new ALS treatment on the healthcare system and Corcept's pricing policy will be as important as the clinical outcomes for long-term commercial success.
MENLO PARK, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- 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 ALS
ALS, 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 Dazucorilant
Dazucorilant 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 Therapeutics
For 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 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 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.
CONTACT
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
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