Corcept Completes Enrollment in Phase 4 CATALYST Trial
Corcept Therapeutics Incorporated has completed enrollment in the Phase 4 CATALYST trial, the largest study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes. Approximately 25% of the over 1,000 patients enrolled were identified as having hypercortisolism, a higher rate than previously assumed. Final prevalence data will be shared at the American Diabetes Association’s 84th Scientific Sessions in June, with treatment data expected by year-end. The findings from CATALYST aim to improve the identification and treatment of patients with hypercortisolism.
- Completion of enrollment in the largest study to establish hypercortisolism prevalence in patients with difficult-to-control type 2 diabetes.
- Anticipation of improved identification and treatment of patients with hypercortisolism through the findings of the CATALYST trial.
- Possibility of encountering challenges in the treatment phase of the study.
- Uncertainty in the impact of the study results on the market value of Corcept Therapeutics Incorporated.
Insights
In analyzing the implications of the CATALYST trial completion by Corcept Therapeutics, one must consider the prevalence of hypercortisolism discovered. The trial's identification of hypercortisolism in roughly
The data's release at a reputable scientific conference and the subsequent treatment data expected by year-end should provide both clinical and financial insights. From a clinical perspective, it could reshape standard medical practices for managing type 2 diabetes with co-existing hypercortisolism. Financially, positive treatment data could lead to increased use of Korlym, affecting Corcept's market share and revenue. Investors should monitor the ADA's 84th Scientific Sessions for the prevalence data, followed by treatment outcomes, to gauge potential commercial impact.
The completion of Corcept's Phase 4 CATALYST trial enrollment marks an important milestone in the lifecycle of Korlym. The drug's efficacy in a large cohort—if proven—could extend its market applicability. For Corcept, which operates in the niche market of cortisol modulation, the success of this trial represents a possible expansion in the drug's label, leveraging its existing FDA approval.
Considering the operational scale of the trial, with over 1,000 patients across 35 sites, Corcept’s operational capabilities and resource allocation will be under scrutiny. The sheer size of the study suggests a significant investment in exploring Korlym's full potential. Investors should pay attention to how the outcomes of the trial might affect Corcept’s operational costs and whether these are offset by a potential increase in Korlym's market penetration, especially if treatment phase results are favorable.
MENLO PARK, Calif., April 29, 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 CATALYST, a Phase 4 trial examining the prevalence of hypercortisolism (Cushing’s syndrome) in patients with difficult-to-control type 2 diabetes; patients with hypercortisolism may enter a randomized, placebo-controlled study of Korlym®.
“With a total enrollment of more than 1,000 patients, CATALYST is the largest study ever conducted to establish the prevalence of hypercortisolism in this patient population,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Approximately 25 percent of the patients enrolled in CATALYST were identified as having hypercortisolism – which is substantially higher than previously assumed for this group. We look forward to sharing final prevalence data at the American Diabetes Association’s 84th Scientific Sessions in June and treatment data by year-end. We expect that the findings from CATALYST will guide physicians to better identify and treat patients with hypercortisolism.”
CATALYST is a prospective, Phase 4 study with two parts. The prevalence phase assesses 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 treatment. Patients from this group with a dexamethasone suppression test value greater than 1.8 µg/dL and dexamethasone levels greater than 140 ng/dL are identified as having hypercortisolism. Subject to satisfying additional screening criteria, these patients are eligible to enter CATALYST’s treatment phase, in which they are randomized, 2:1, to receive treatment with either Korlym or placebo for 24 weeks. CATALYST is being conducted at 35 sites in the United States.
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 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: 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
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