Corcept Announces Presentation of Results From Prevalence Phase of CATALYST Clinical Trial at American Diabetes Association’s Scientific Sessions

Rhea-AI Summary

Corcept Therapeutics announced results from the prevalence phase of their CATALYST clinical trial at the American Diabetes Association’s 84th Scientific Sessions.

The trial enrolled 1,055 patients with difficult-to-control type 2 diabetes across 36 U.S. sites, making it the largest study of its kind. The results showed a 24% prevalence rate of hypercortisolism among these patients, a higher figure than previously assumed.

Hypercortisolism was notably common in patients with cardiovascular issues and those needing multiple medications for diabetes and hypertension control.

This new data may lead to better diagnosis and treatment strategies for hypercortisolism, a serious condition often overlooked in type 2 diabetes management.

Details of the treatment phase, where eligible patients received either Korlym or a placebo, are expected by year-end.

Positive

• Largest and most rigorous study conducted on hypercortisolism in difficult-to-control type 2 diabetes, with 1,055 patients.
• Hypercortisolism prevalence found to be 24%, higher than previously assumed, providing new insights for diagnosis and treatment.

Negative

• Prevalence of hypercortisolism suggests that many patients might have been misdiagnosed or underdiagnosed previously.

Medical Research Analyst

The findings from the CATALYST trial have important clinical implications. The study revealed a significant prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes—24%. This rate challenges the previously held belief that hypercortisolism is rare in this population. For medical practitioners, this new insight may lead to more frequent screening for hypercortisolism among their diabetes patients. Diagnosing and treating hypercortisolism early could potentially improve the management of type 2 diabetes, offering better health outcomes for these patients. From a clinical perspective, this could reshape treatment protocols and encourage the use of cortisol-modulating therapies such as Korlym®, Corcept's medication. Given that clinicians might need to adopt new diagnostic procedures, the financial burden on healthcare systems could increase in the short term but might result in long-term cost savings through better disease management and reduced complications. For a retail investor, understanding the medical community's growing focus on hypercortisolism can highlight potential market expansion for Corcept's treatments.

Financial Analyst

The CATALYST trial results could have several financial implications for Corcept Therapeutics. With hypercortisolism affecting 24% of patients with difficult-to-control type 2 diabetes, Corcept's market for Korlym® could expand considerably. This could result in increased revenues if the medical community adopts more widespread screening and treatment for hypercortisolism. Additionally, if the treatment phase of the CATALYST trial, whose results are expected by year-end, confirms positive outcomes for Korlym®, the company's financial outlook may improve substantially. Investors should monitor these upcoming results as they could be a significant catalyst for the stock price. However, it is also essential to consider the cost implications associated with expanded screenings and the potential for insurance coverage debates, which could impact the adoption rate. Balancing these factors will be important for investors to gauge the long-term financial impact of these findings.

• Results from the CATALYST clinical trial were presented at the American Diabetes Association’s 84^th Scientific Sessions at a featured plenary session titled: “Prevalence of Hypercortisolism in Difficult-to-Control Type 2 Diabetes”
• With 1,055 patients enrolled, CATALYST is the largest and most rigorous study ever conducted to assess the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes
• Results demonstrate a hypercortisolism prevalence rate of 24 percent in this patient population
  

MENLO PARK, Calif., June 24, 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 results from the prevalence phase of its CATALYST study of hypercortisolism (Cushing’s syndrome) in patients with difficult-to-control type 2 diabetes were presented at the American Diabetes Association’s 84^th Scientific Sessions.

CATALYST enrolled 1,055 patients across 36 sites in the U.S., making it the largest and most rigorous study ever conducted to assess the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes. Of the patients enrolled in CATALYST, 24 percent were identified as having hypercortisolism. Hypercortisolism was more common in patients with cardiovascular disease, particularly in those who needed multiple medications to manage their hypertension. It was also more common in those taking more medication to manage their diabetes.

“Until now, hypercortisolism has been widely regarded as extremely rare. But that turns out not to be true. These results show that hypercortisolism among patients with difficult-to-control type 2 diabetes is much more common than previously assumed and is likely the underlying cause of diabetes in many cases,” said Ralph DeFronzo, MD, chief of the Diabetes Division and professor of medicine at UT Health San Antonio and CATALYST study investigator. “These insights should lead to expanded screening for hypercortisolism, more effective treatment and better health outcomes for patients who are struggling today."

“Physicians haven’t been looking for hypercortisolism in their patients with difficult-to-control type 2 diabetes because they didn’t know how common it is,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “These data will enable physicians to more accurately diagnose and treat patients with hypercortisolism - a serious and deadly disease.”

CATALYST is a prospective, Phase 4 study with two parts. The prevalence phase assessed the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes, which the study defines as hemoglobin A1c greater than 7.5 percent despite receiving optimal therapies, including GLP-1 agonists. Patients from this group with a dexamethasone suppression test (DST) value greater than 1.8 µg/dL and dexamethasone levels greater than 140 ng/dL were identified as having hypercortisolism. Subject to satisfying additional screening criteria, these patients were eligible to enter CATALYST’s treatment phase, in which they were randomized, 2:1, to receive treatment with either Korlym^® or placebo. Results of the treatment phase will be available by year-end.

Additional details about the presentation are as follows:

American Diabetes Association 84th Scientific Sessions, Orange County Convention Center
Session: Prevalence of Hypercortisolism in Difficult-to-Control Type 2 Diabetes
Session Chair: Rodica Pop-Busui, MD
Presenters:

• The Spectrum of Hypercortisolism: An Evolution of Understanding – Richard Auchus, MD
• Pathologic Mechanisms of Hypercortisolism in Type 2 Diabetes – Ralph DeFronzo, MD
• Rationale for and Design of the CATALYST Trial – Athena Philis-Tsimikas, MD
• Results of the CATALYST Trial Part 1 – Vivian Fonseca, MD
• Clinical Implications of the CATALYST Trial Part 1 – John Buse, MD
  

About Hypercortisolism (Cushing’s Syndrome)
Hypercortisolism is caused by excessive activity of the endogenous hormone cortisol. Symptoms of hypercortisolism vary, but most patients experience one or more of the following manifestations: elevated blood sugar, difficult-to-control type 2 diabetes, hypertension, central 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. Hypercortisolism can affect every organ system and can be lethal if not treated effectively.

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 expressed or implied by such statements. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym^®, relacorilant, miricorilant, dazucorilant and our other product candidates, as well as those molecules’ 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: the design, timing, expectations and results of our CATALYST trial and its impact on the medical field’s rate of screening for and treatment of hypercortisolism. 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 were the results of the CATALYST clinical trial presented by Corcept Therapeutics?

The CATALYST clinical trial revealed a 24% prevalence rate of hypercortisolism in patients with difficult-to-control type 2 diabetes.

When and where were the results of the CATALYST clinical trial presented?

The results were presented at the American Diabetes Association’s 84th Scientific Sessions on June 24, 2024.

How many patients were enrolled in the CATALYST clinical trial by Corcept Therapeutics (CORT)?

The CATALYST clinical trial enrolled 1,055 patients.

What significant findings did the CATALYST study reveal about hypercortisolism in type 2 diabetes patients?

The study found a 24% prevalence of hypercortisolism among patients with difficult-to-control type 2 diabetes.

What implications does the CATALYST trial have for the treatment of patients with difficult-to-control type 2 diabetes?

The findings suggest that routine screening for hypercortisolism could lead to better diagnosis and more effective treatment for these patients.