Quotient Clinical delivers breakthrough first-in-human program for Corcept Therapeutics

15-Jun-2015 - United Kingdom

Quotient Clinical has announced the successful completion of an Enabled-First-in-Human® (Enabled-FIH) program for 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. 

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