Corcept Announces Primary Endpoint Met in Pivotal Phase 3 GRACE Trial of Relacorilant in Patients With Hypercortisolism (Cushing’s Syndrome)
Corcept Therapeutics (NASDAQ: CORT) announced positive results from its Phase 3 GRACE trial of relacorilant for treating hypercortisolism (Cushing’s syndrome). The trial met its primary endpoint, showing significant improvements in hypertension, hyperglycemia, and other symptoms. In the randomized withdrawal phase, patients receiving relacorilant had a notably lower loss of blood pressure control compared to those on placebo (odds ratio: 0.17; p-value: 0.02). The drug was well-tolerated, with no significant safety differences observed. Corcept plans to submit a New Drug Application in Q3, with additional data presentations scheduled for June.
- GRACE trial met its primary endpoint with significant improvements in hypertension and hyperglycemia.
- Patients on relacorilant were 5.9 times more likely to maintain their hypertension response compared to placebo.
- Relacorilant was well-tolerated with no significant safety differences between relacorilant and placebo groups.
- Corcept plans to submit a New Drug Application in Q3.
- Upcoming data presentations at the Endocrine Society and Heart in Diabetes conferences.
- The press release does not mention specific financial data or projections.
- No detailed data on long-term benefits or potential side effects beyond the 12-week phase.
Insights
This news about Corcept Therapeutics meeting the primary endpoint in their GRACE Phase 3 trial for relacorilant is a major development in the realm of treatments for hypercortisolism, commonly known as Cushing’s syndrome. Cushing's syndrome is a serious condition caused by prolonged exposure to high levels of cortisol and it often leads to severe complications such as hypertension and hyperglycemia.
Relacorilant has shown statistically significant benefits in managing these symptoms, marking a crucial step forward in treatment options for patients suffering from hypercortisolism. The fact that the drug was well-tolerated with no significant safety concerns in the trial adds to its potential as a viable treatment option. The odds ratio of 0.17 with a p-value of 0.02 is particularly notable; this indicates a strong effect size and statistical significance, reinforcing the robustness of the trial results.
For retail investors, this development suggests that Corcept Therapeutics is moving closer to potentially securing FDA approval for relacorilant, which can translate into significant market opportunities. However, investors should also be wary of the competitive landscape and ongoing regulatory hurdles. The upcoming presentations at major medical conferences will be pivotal for gauging reception within the medical community.
From a financial standpoint, the positive results from the Phase 3 GRACE trial could be a catalyst for Corcept Therapeutics’ stock performance. Meeting the primary endpoint in a Phase 3 trial is a significant milestone that typically precedes the submission of a New Drug Application (NDA) to the FDA, scheduled for the third quarter. If approved, relacorilant could open up a lucrative market segment for Corcept, particularly given the unmet medical need in treating hypercortisolism.
Positive clinical outcomes often lead to increased investor confidence, potentially driving up the stock price. Additionally, the upcoming data presentations at the Endocrine Society meeting and the Heart in Diabetes conference will provide further visibility and validation, possibly attracting more institutional investors. However, it’s essential to consider the costs associated with bringing a new drug to market, including regulatory approval, manufacturing and marketing expenses. Hence, while the immediate outlook seems promising, long-term financial success will depend on market adoption and competitive dynamics.
MENLO PARK, Calif., May 28, 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 that GRACE, the Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with hypercortisolism (Cushing’s syndrome), met its primary endpoint.
The GRACE study has two parts. On April 22, Corcept announced that patients in GRACE’s initial, open-label phase exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia and other symptoms experienced by patients with Cushing’s syndrome. Patients who exhibited pre-specified improvements in hypertension, hyperglycemia or both were given the opportunity to enter the trial’s randomized, double-blind withdrawal phase, in which half of the patients continued to receive relacorilant and half received placebo, for 12 weeks.
GRACE met its primary endpoint of loss of blood pressure control in the randomized withdrawal phase among patients receiving relacorilant as compared to placebo (odds ratio: 0.17; p-value: 0.02). Consistent with its known safety profile, relacorilant was well-tolerated in both phases of GRACE, with no differences in the randomized withdrawal phase between the relacorilant and placebo groups. Additional data will be presented at the Endocrine Society (ENDO) annual meeting in Boston (poster presentation, June 3) and the Heart in Diabetes (HiD) conference in Philadelphia (oral presentation, June 7). The company expects to submit its New Drug Application in the third quarter.
“The data from GRACE make a compelling case for the use of relacorilant in patients with endogenous hypercortisolism. That patients experienced clinically significant improvements in hypertension, hyperglycemia and the other signs and symptoms of Cushing’s syndrome, without significant safety burden, is greatly encouraging for physicians and the patients they seek to help,” said Rosario Pivonello, MD, PhD, Principal Investigator of the GRACE study and Professor of Endocrinology at Università Federico II di Napoli, Italy.
“GRACE’s clearly positive results are a welcome development for patients and constitute a significant step toward our new drug application for relacorilant,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Patients receiving relacorilant exhibited rapid and sustained improvements in hypertension and were 5.9 times more likely to maintain their hypertension response compared to patients receiving placebo. We plan to present data from the open-label and randomized withdrawal phases of GRACE at medical conferences in June.”
About Relacorilant
Relacorilant 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 relacorilant in a variety of serious disorders in addition to Cushing’s syndrome, including ovarian, adrenal and prostate cancer. 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 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, amyotrophic lateral sclerosis (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 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: relacorilant, including its clinical attributes and potential to become a treatment for patients with Cushing’s syndrome or any other disorder, the conduct, pace and outcome of GRACE, regulatory oversight of relacorilant, the timing of relacorilant’s NDA submission and its prospects for approval by the FDA and other authorities, relacorilant’s acceptance and use by physicians and patients and its commercial prospects, and the scope and protective power of relacorilant’s orphan drug designation and our intellectual property. 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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