Quotient Clinical has completed an Enabled-First-in-Human (Enabled-FIH) program for U.S. biotech company Corcept Therapeutics, 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 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.

“We were delighted to be chosen as Corcept Therapeutics’ partner for this development program,” said Mark Egerton, chief executive officer, Quotient Clinical. “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 Hazel Hunt, vice president of research, Corcept Therapeutics. “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.”