Date: 2015-03-30
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Diurnal Limited (UK)
Product: Infacort® (hydrocortisone oral granules)
Action
mechanism: hormone/corticosteroid. Infacort® is a preparation of hydrocortisone specifically designed for use in children suffering from adrenal insufficiency . It is an immediate-release, oral formulation of hydrocortisone with the potential to significantly improve the lives of children living with adrenal insufficiency.
Disease: pediatric adrenal insufficiency
Therapeutic area: Rare diseases - Endocrine diseases - Hormonal diseases
Country: Germany
Trial
details: 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 (EudraCT Number: 2014-002265-30)
Latest
news: * On March 30, 2015, Diurnal Limited, a specialty pharmaceutical company focused on developing treatments for rare and chronic endocrine conditions, announced 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.
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.
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”.
