Cardiff, UK – Diurnal Limited, a specialty pharmaceutical company focused on developing treatments for rare and chronic endocrine conditions, is pleased to announce today that the first patient has been enrolled onto a Phase 3 trial of its paediatric product - Infacort® (immediate release hydrocortisone). The Infacort 003 trial is a European registration trial in paediatric patients who are less than six years of age with the rare condition Adrenal Insufficiency. The Infacort® trial is scheduled to be completed by Q3, 2016.
About Adrenal Insufficiency
Adrenal Insufficiency (AI) is a condition characterised by deficiency in cortisol, an essential hormone in 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. Currently there are no licensed hydrocortisone preparations in Europe to treat these young patients with children often administered compounded adult tablets or other unlicensed products. Poor control of disease can result in precocious puberty in young children leading to virilisation and infertility, combined with 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 release of cortisol in a manner that mimics current clinical practice. This therapeutic approach has the potential to help young patients less than six year of age suffering from diseases due to cortisol deficiency including adrenal insufficiency. AI requires life-long treatment and Diurnal’s novel approach to drug delivery has the potential to significantly improve these young patients’ lives. The European Medicines Agency has already approved a Paediatric Investigation Plan (EMEA-001283-PIP01-12) for Infacort®, which sets out the regulatory pathway to market authorisation via the Paediatric Use Marketing Authorisation (PUMA) route.
Martin Whitaker, CEO 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 important therapy that could deliver patient benefits to young children living with adrenal insufficiency”.
The Infacort 003 trial is funded by the European Commission under an EU Framework 7 grant (HEALTH-FP7; Project No: 281654) TAIN “Treatment of Adrenal Insufficiency in Neonates and Infants”. For further information see: www.tain-project.org
Please direct all enquiries to:
Martin Whitaker, CEO
+44 (0)871 716 8848