Corcept Therapeutics Incorporated, a pharmaceutical company, engages in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol. Cushing’s Syndrome In 2012, the United States Food and Drug Administration (FDA) approved Korlym (mifepristone) 300 mg tablets as a once-daily oral medication for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. The company received Orphan Drug designation from the FDA in 2007 for Korlym for the treatment of endogenous Cushing’s syndrome. The company sells Korlym using experienced sales representatives, who target the approximately 1,500 endocrinologists who care for a major portion of the Cushing’s syndrome population. The company also reaches patients directly through Web-based initiatives and interactions with patient groups. In addition, the company has a field-based force of medical science liaisons. The company uses a specialty pharmacy and a specialty distributor to distribute Korlym and provides logistical support. By the end of the first quarter of 2016, the company plans to begin a Phase 2 trial of its proprietary, selective cortisol modulator CORT125134 to treat patients with Cushing’s syndrome. CORT125134 shares Korlym’s affinity for glucocorticoid receptor (GR). Data from its Phase 1 trial showed that it could potently reverse the effects of the steroid prednisone, a commonly-used GR agonist, on serum osteocalcin, white blood cell counts, glucose metabolism and genetic markers of GR activation. Phase 1 pharmacokinetic data indicate that CORT125134 is suitable for once-daily oral dosing. Oncology Program In 2014, the company began a Phase 1/2 trial of Korlym in combination with eribulin to treat metastatic triple-negative breast cancer, a form of the disease in which the three receptors that fuel most tumor growth – estrogen, progesterone and the HER-2/neu gene – are not present. The company has begun the efficacy phase of its Phase 1/2 trial and plans to enroll 20 patients with metastatic triple-negative breast cancer. The company expects to have results by the end of the second quarter of 2016. The company plans to study CORT125134 in combination with anti-cancer agents to treat a range of solid-tumor cancers. The company’s Phase 1/2 trial’s first stage, which the company plans to start by the end of the first quarter of 2016, would identify the maximum tolerated dose of a chemotherapeutic agent and CORT125134. The trial’s second stage would test that combination’s efficacy against one or more solid-tumor cancers. As the company gathers data from its own research and the work of its academic collaborators, the company might include other anti-cancer agents and solid-tumor cancers in the trial. Proprietary, Selective Cortisol Modulators CORT125134 is the major compound in the company’s portfolio of proprietary selective cortisol modulators. There are three structurally series of these compounds, all of which like Korlym, potently block GR but do not block the progesterone, estrogen, androgen or mineralocorticoid receptors. Both the United States Patent & Trademark Office and the European Patent Office have issued to the company composition of matter patents related to these compounds. One additional composition of matter patent application is pending. In addition to the company’s findings with CORT125134, several of its new compounds have demonstrated positive results in animal or in vitro models in various indications, including but not limited to, the prevention and reversal of alcohol dependence; Alzheimer’s disease; post-traumatic stress disorder; electroconvulsive-induced retrograde amnesia; amyotrophic lateral sclerosis (ALS or Lou Gehrig’s Disease); muscular dystrophy; prevention of glucocorticoid-induced neurological damage in premature infants; anti-psychotic-induced weight gain; fatty liver disease; metabolic syndrome; obesity; and breast, ovarian and prost
corcept therapeutics inc
149 Commonwealth Drive
Menlo Park, CA 94025
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