16th September 2013

Diurnal announces positive progress in Chronocort Phase 2 trial

Fusion IP plc (AIM: FIP), the university commercialisation company that turns world-class research into business, is pleased to announce that its portfolio company, Diurnal, a spin-out from the University of Sheffield, 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%.

Peter Grant, Operations Director of Fusion IP, commented:

“We remain very excited about Diurnal’s prospects. Successful completion of the Phase 2 trial and progression into Phase 3 will be a significant event for the company.”

Martin Whitaker, Chief Executive Officer of Diurnal Ltd, added:

“Diurnal is delighted to have completed the first pharmacokinetic part of the CATCH study which will support the on-going development of Chronocort®.”