Fusion IP plc : Fusion portfolio company ‘Diurnal’, announces successful completion of a clinical trial for ‘Chronocort’, a novel hydrocortisone formulation

Fusion IP (AIM: FIP), the university commercialisation company which turns university research into business, is pleased to announce that Diurnal's lead product, Chronocort®, has successfully completed a clinical trial in healthy volunteers. The trial involved the administration in humans of different formulations of Chronocort® followed by blood measurements of hydrocortisone taken over time. As a result of the trial, the formulation giving the hydrocortisone profile most closely resembling that of the naturally occurring hormone has now been chosen to be tested in a further clinical trial to demonstrate dose response.

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). 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 company hopes to move  into Phase II trials during 2012, with an estimated Phase II completion date of mid-2013.

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

FusionIP has a 43.1 % shareholding in Diurnal.

Peter Grant, Operations Director for Fusion IP, commented:

"We are very pleased with this clinical result. A major challenge for the Chronocort concept was to show that it could mimic the natural levels of the hormone it needs to replace in humans. The formulation of choice needs to be further tested but a major development objective has been achieved with a concomitant increase in the value of the Chronocort offering. The company has the funds to complete its Phase 1 and 2 trials and although it is hard to estimate what the value will be at the end of Phase 2, it is notable there has been acquisition activity involving a similar drug in a comparable indication which attracted high value."

Martin Whitaker, General Manager at Diurnal Ltd, added:

"These results for Chronocort® were excellent and hit all the set target success parameters.  We hope to progress to Phase 2 rapidly.  This is a very exciting time for the company."

Melanie Goward, Senior Investment Executive at Finance Wales, commented:

"This is an excellent clinical result for Diurnal and also a key milestone. We're pleased our investment has helped the company to get to this point and we're looking forward to seeing successful progress in Phase 2."