Quotient Clinical, the Translational Pharmaceutics® Company, has announced the successful completion of an Enabled-First-in-Human® (Enabled-FIH) program for US biotech company Corcept Therapeutics Incorporated, focusing on a next generation selective glucocorticoid receptor antagonist (CORT125134) in development for the treatment of Cushing’s syndrome and certain cancers.
The Enabled-FIH program integrated formulation development, real-time GMP manufacturing and clinical testing, using a single adaptive protocol to assess single and multiple dose safety, pharmacokinetics, and proof of pharmacological effect. The clinical timeline for the first-in-human dose through to completion of the program was only 7 months. CORT125134 was proven to be safe and well tolerated at the doses tested, and pharmacological effect was demonstrated. The drug is now progressing into the next stages of development.
Mark Egerton, CEO of Quotient Clinical, commented: “We were delighted to be chosen as Corcept Therapeutics’ partner for this development program. CORT125134 is an exciting new potential drug, and our Enabled-FIH service has helped to accelerate its early development timeline and deliver significant cost savings. This program again demonstrates how Enabled-FIH represents an important step forward, helping the industry to improve overall R&D productivity.”
“CORT125134 has great therapeutic potential,” said Dr Hazel Hunt, Corcept’s Vice President of Research. “Quotient’s innovative and flexible approach allowed us to complete initial clinical testing quickly and produce evidence of functional activity that will guide the compound’s subsequent development.”
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About Quotient Clinical
Quotient Clinical offers unique services – based on its Translational Pharmaceutics® – that integrate formulation development, real-time drug product manufacturing and clinical testing, 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 right 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 competitively block 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.