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Results of Phase 1 Trial of Next-Generation Cortisol Modulator CORT125134 to be Presented at Annual Meeting of the American Association of Pharmaceutical Scientists

Design and outcome of trial to be discussed in webinar broadcast October 14, 2015

Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, oncologic and psychiatric disorders, announced today that a poster describing the Phase 1 trial results of its next-generation cortisol modulator CORT125134 will be presented at the annual meeting of the American Association of Pharmaceutical Scientists in Orlando, Florida on October 28, 2015.

The poster, entitled “Assessment of Safety, Tolerability, Pharmacokinetics, Proof of Concept and Proof of Pharmacological Effect of Orally Administered CORT125134 Using an Adaptive Clinical Protocol,” will be presented by Quotient Clinical, the Nottingham, UK-based drug development organization that Corcept selected to conduct the trial. For the presentation’s precise time and location, visit http://www.quotientclinical.com/events.

Corcept chose Quotient Clinical because of Quotient’s ability to carry out formulation development, rapid drug product manufacturing and clinical testing in a single facility. “Quotient’s integrated approach to development allowed us to respond to the challenges inherent in clinical trials quickly and cost-effectively,” said Dr. Hazel Hunt, Corcept’s Vice President of Research. “These capabilities are especially valuable to Corcept as we begin advancing more new compounds to the clinic.”

Upcoming Webinar

Dr. Hunt will discuss the design, conduct and outcome of the Phase 1 trial in a webinar hosted by Quotient entitled “Accelerating Timelines from Candidate Selection to Proof-Of-Concept with Enabled-FIH® Programs,” which will be broadcast at 9:00am, PDT, on October 14, 2015. Dr. Hunt will be joined by Alyson Connor, Quotient Clinical’s Executive Director of Exploratory Clinical Pharmacology. For registration and webinar replay information, visit http://www.quotientclinical.com/webinars.

Corcept’s Cortisol Modulation Platform

Corcept’s first-generation cortisol modulator, Korlym®, was approved by the U.S. Food and Drug Administration in 2012 for the treatment of endogenous Cushing’s syndrome, an orphan disease that afflicts approximately 20,000 people in the United States.

CORT125134 is the lead compound in Corcept’s portfolio of next-generation cortisol modulators. It was well-tolerated in its Phase 1 trial, where it also demonstrated that it shares Korlym’s ability to potently modulate activity at the glucocorticoid receptor, a necessity in treating Cushing’s syndrome and a potential treatment for a variety of other metabolic illnesses. When administered in conjunction with chemotherapeutic agents, CORT125134 also slows tumor growth significantly in models of triple negative breast cancer, castrate resistant prostate cancer and ovarian cancer. Corcept plans to begin separate Phase 2 trials of CORT125134 for the treatment of Cushing’s syndrome and an oncology indication in the first quarter of 2016.

About Korlym®

Korlym (mifepristone) competitively blocks the glucocorticoid receptor (GR), thereby modulating the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for Cushing’s syndrome and the FDA has designated it as an Orphan Drug.

About CORT125134

CORT125134 is a potent modulator of GR, one of the two receptors to which cortisol normally binds, but has no affinity for the progesterone, estrogen, androgen or mineralocorticoid receptors.

About Cushing’s Syndrome Endogenous

Cushing’s syndrome is caused by prolonged exposure of the body's tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s syndrome is an orphan indication that most commonly affects adults aged 20-50. An estimated 10-15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients annually in the United States. An estimated 20,000 patients in the United States have Cushing’s syndrome, half of whom are cured by surgery. Symptoms vary, but most people have 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 in the body and can be lethal if not treated effectively.

About Quotient Clinical

Quotient Clinical offers unique services – based on its Translational Pharmaceutics® platform – that integrate formulation development, real-time drug product manufacturing and clinical testing, thereby significantly reducing the time and cost of bringing a drug to market. For more than 20 years, Quotient Clinical has brought innovation to drug product development programs for pharmaceutical and biotechnology customers worldwide. The company is based in purpose-built, fully integrated facilities in Nottingham, UK, where formulation development, real-time GMP manufacturing and early clinical trials are performed in the same facility. It employs over 250 staff, offering a full range of support services, from study set-up through to data analysis and reporting.

About Corcept Therapeutics Incorporated

Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, oncologic and psychiatric disorders. Korlym, a first generation competitive GR antagonist, is the company’s first FDA-approved medication. The company is conducting a Phase 1/2 trial of mifepristone for the treatment of triple-negative breast cancer and is planning Phase 2 studies of CORT125134, one of its next-generation selective GR antagonists, for the treatment of Cushing’s syndrome and an oncology indication. The company has developed a proprietary portfolio of other selective GR antagonists that modulate the effects of cortisol, but not progesterone. It owns or has exclusively licensed extensive intellectual property covering the use of GR antagonists, including mifepristone, in the treatment of a wide variety of metabolic, oncologic and psychiatric disorders. It also holds composition of matter patents for its selective GR antagonists.

Investor Contact

Charles Robb, Corcept Therapeutics Incorporated
Chief Financial Officer
crobb@corcept.com
650-688-8783

 

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