04/09/2013

Diurnal announces positive progress in Chronocort® Phase 2 trial

Finance Wales and Fusion IP, the majority shareholders in Diurnal, are pleased to announce that the Company has successfully completed the pharmacokinetic part of its Phase 2 CATCH (Chronocort® As Treatment for Congenital Adrenal Hyperplasia) clinical study.

Based in Cardiff, Diurnal is developing a novel approach to drug delivery that will help patients suffering from reduced levels of the key hormone cortisol (hydrocortisone). Pharmacokinetic data from the first part of the CATCH study has been received by Diurnal. The CATCH trial will now continue until the end of 2013 so that further data can be collected to support a Phase 3 registration study of Chronocort®.  The full read-out of the CATCH study is expected during Q1, 2014.

Chronocort® is a modified release therapy that delivers hydrocortisone in a manner that mimics the body’s normal circadian rhythm (the body’s natural, 24-hour hormone cycle). This therapeutic approach has the potential to help patients suffering from diseases due to cortisol deficiency: congenital adrenal hyperplasia and adrenal insufficiency. Each of these diseases requires life-long treatment and Diurnal’s novel approach to drug delivery has the potential to significantly improve patients’ lives.

The CATCH trial is a Phase 2 study in patients suffering from Congenital Adrenal Hyperplasia and is being run by the National Institute of Health (NIH), Maryland, US under a Cooperative Research and Development Agreement (CRADA).

Chronocort® has already received two related Orphan Drug designations from the European Medicines Agency, which afford ten years of market exclusivity after the grant of marketing authorisation in Europe.

Fusion’s shareholding in Diurnal is 43.42%.

David Baynes, CEO of Fusion IP, commented: “ This is an excellent announcement for Diurnal and we are excited about their prospects.  The successful completion of the Phase 2 study and progression into a Phase 3 trial will be a major value changing event for the company.”

Steve Smith, Director, Technology Venture Investments at Finance Wales, added: "Diurnal is one of Finance Wales’ leading portfolio companies. The successful progression of these trials is very encouraging and we will be working in partnership with Diurnal’s management team and co-investors to support the continued development of this very exciting business.”