Corcept Completes Enrollment in Phase 3 Gradient Trial of Relacorilant in Patients With Adrenal Cushing’s Syndrome
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Insights
The completion of enrollment for the GRADIENT Phase 3 trial by Corcept Therapeutics marks a pivotal moment in the development of relacorilant, particularly for those with Cushing's syndrome stemming from adrenal issues. The focus on selective cortisol modulation is a significant stride in endocrinology, as cortisol excess is a key factor in the syndrome's severe symptoms and complications. The primary endpoints, improvement in glucose metabolism and hypertension, are critical as these are common co-morbid conditions that significantly impact patient quality of life and long-term health outcomes. If relacorilant proves effective, it could lead to a paradigm shift in how Cushing's syndrome is managed, potentially improving the prognosis for patients who currently have limited treatment options.
From a market perspective, Corcept's announcement is likely to be closely monitored by investors and competitors alike. The Cushing's syndrome treatment market is not overly saturated, which means a successful trial could position Corcept as a leader in this niche. The trial's double-blind, placebo-controlled design is the gold standard for determining drug efficacy, which can enhance investor confidence if the results are positive. Moreover, the mention of a Q4 data release sets a clear timeline for potential market movement. The anticipation of these results could influence Corcept's stock volatility as the market reacts to both rumors and actual data releases.
As a methodologist, the design of the GRADIENT trial warrants attention. The randomized, double-blind, placebo-controlled structure minimizes bias and enhances the credibility of the results. The 22-week duration and the 1:1 randomization ratio are standard for ensuring adequate exposure and comparison. However, the true test will be in the trial's ability to show statistically significant differences between the relacorilant and placebo groups. The focus on glucose metabolism and hypertension as primary endpoints is appropriate, as these are quantifiable and clinically relevant outcomes that can be directly linked to patient well-being and the drug's potential market value.
MENLO PARK, Calif., April 01, 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 GRADIENT, a Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with Cushing’s syndrome (hypercortisolism) caused by an adrenal adenoma or adrenal hyperplasia.
“Hypercortisolism with adrenal etiology affects many patients and is associated with serious cardiometabolic comorbidities, including hypertension and hyperglycemia, and increased risk of premature death,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “GRADIENT is the first prospective placebo-controlled study to be conducted exclusively in these patients with Cushing’s syndrome. We expect data from GRADIENT in the fourth quarter of this year.”
GRADIENT is a randomized, double-blind, placebo-controlled trial conducted at sites in the United States, Europe and Israel. One-hundred thirty-seven patients were randomized 1:1 to receive relacorilant or placebo for 22 weeks. Primary endpoints are improvement in glucose metabolism and hypertension.
About Cushing’s Syndrome (Hypercortisolism)
Cushing’s syndrome is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system and can be lethal if not treated effectively.
About Relacorilant
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor (GR), but does not bind to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, adrenal and prostate cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. Relacorilant has orphan drug designation in the United States and the European Union for the treatment of Cushing’s syndrome.
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 include, but are not limited to, our ability to operate our business; risks related to the study and development of Korlym as well as relacorilant, miricorilant, dazucorilant and our other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks 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 relacorilant as a treatment for Cushing’s syndrome, and design, timing and expectations regarding our GRADIENT trial. 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
FAQ
What is the purpose of the Phase 3 trial GRADIENT by Corcept Therapeutics (CORT)?
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