14th December 2016 – Nottingham, UK – Sygnature Discovery has released a biology publication focusing on our collaboration with Corcept Therapeutics. This work highlights our biomarker validation work and reports the outcome of phase I QBR116598 study that was also recently presented at Sygnature by Quotient clinical. The publication, sets the scene to support further phase II studies where FKBP5 might be utilized as a predictive biomarker to assess the treatment response of patients with Cushing’s syndrome.
To summarize, the publication highlights the discovery and validation of FKBP5 as a biomarker for GR antagonism and showcases the quantitative PCR assay, used to detect the FKBP5 mRNA transcript levels, from total RNA extracted from whole blood. Follow up analysis of FKBP5 levels in phase II trial, investigating the effect of CORT125134 in patients with Cushing’s disease, will be carried out at US based Neogenomics. They will be aiming to use their cGCP platform to platform to determine FKBP5 mRNA transcripts in these samples.
Dr Hazel Hunt, Vice President, Research at Corcept Therapeutics stated;
‘The measurement of FKBP5 provides a simple and convenient method to assess the activity of cortisol, the endogenous agonist of the glucocorticoid receptor. Disregulated cortisol production is associated with many diseases, including the archetypal disease of cortisol excess, Cushing’s syndrome’.
The publication has been released in the peer reviewed Journal of Clinical Endrocrinology and Metabolism and an online link to the Early Release version of the manuscript can be accessed via this link at the journal website