OREANDA-NEWS. April 06, 2015. IP Group plc (LSE: IPO) ("IP Group" or "the Group"), the developer of intellectual property-based businesses, is pleased to note that portfolio company Diurnal Limited ("Diurnal") has today announced that the first patient has been enrolled onto a Phase 3 trial of its paediatric product Infacort®. This is the first Phase 3 study for Diurnal's portfolio of late-stage products targeted at rare disorders of the endocrine system.

Diurnal, a spin-out company from the University of Sheffield and in which IP Group holds a 51.7% undiluted beneficial interest, is developing Infacort® for the treatment of paediatric adrenal insufficiency (AI).  The Phase 3 trial is due to be completed by the third quarter of 2016 and is funded by the European Commission under an EU Framework 7 grant "Treatment of Adrenal Insufficiency in Neonates and Infants" (TAIN).     

AI is a condition characterised by a deficiency in cortisol, an essential hormone for regulating metabolism and the response to stress. AI has been identified as an orphan disease in Europe where there are estimated to be approximately 4,000 sufferers younger than the age of six. While hydrocortisone (synthetic cortisone) represents the obvious treatment for paediatric AI, there is currently no licensed hydrocortisone preparation in Europe for the condition. As a consequence, young patients are often administered crushed versions of the adult tablet and other, unlicensed products. This results in variable dosing and poor control of the disease, which can be associated with precocious puberty, virilisation, fatigue and a poor quality of life in adulthood.

Infacort® represents the first ever preparation of hydrocortisone specifically designed for use in children suffering from AI. It is a patented, immediate-release, oral, paediatric formulation of hydrocortisone that allows for the release of cortisol in a reliable, consistent manner. Diurnal is developing Infacort® under a Paediatric Investigation Plan approved by the European Medicines Agency,which sets out the regulatory pathway to market authorisation via the Paediatric Use Marketing Authorisation (PUMA) route.

Alan Aubrey, Chief Executive of IP Group, said: "This is a major milestone for Diurnal as it seeks to progress the first drug to specifically address adrenal insufficiency in young children towards market authorisation. It is also extremely important for IP Group as this represents the first of the Group's portfolio companies to enter a product into a Phase 3 trial and demonstrates further strong progress in the Biotech division. Following the recent strengthening of the Group's balance sheet, we intend to continue to support Diurnal, and selected other companies like it, through late-stage clinical development and eventual market launch, something that is considered possible in the specialised markets in which Diurnal operates."

Martin Whitaker, Chief Executive of Diurnal,said: "The start of the Infacort® study marks a significant achievement by the Diurnal team.  We are delighted to have reached this development milestone and are very excited about the potential opportunity for this product.  This Phase 3 trial has the potential to demonstrate the safety and efficacy profile of a new and important therapy that could deliver patient benefits to young children living with adrenal insufficiency."