Fusion IP (AIM: FIP), the university commercialisation company which turns university research into business, is pleased to note that its portfolio company, Diurnal, is a major partner in a new EU collaborative research programme for the Treatment of Adrenal Insufficiency in Neonates (TAIN). The programme will, for the first time, create a regulatory approved paediatric version of hydrocortisone, specifically for neonates and infants who suffer from the rare disease adrenal insufficiency. Children who suffer from adrenal insufficiency cannot produce adequate amounts of the essential stress hormone cortisol and need to administer hydrocortisone as a replacement. The problem of effective hydrocortisone replacement is especially acute in this paediatric setting where no licensed therapies exist.
TAIN is a collaborative project that involves European leaders in drug development, neonatology and paediatric pharmacology who will work together to create, develop and trial a new formulation of hydrocortisone – Infacort®. This grouping of partners has a strong SME focus enabling these innovative organisations to rapidly bring new pharmaceutical products to market in niche therapeutic areas. Under a Paediatric Investigation Plan, clinical trials will be carried out to provide sufficient evidence of safety and efficacy for Infacort® to allow submission of a Paediatric Use Medicines Authorisation (PUMA) to the European Medicines Agency by the end of 2015 and its subsequent use in patients.
Peter Grant, Fusion IP added
“This is a prestigious award for Diurnal who will be taking a leading role in this project. With potentially over €1.6M in EU contribution being allocated to Diurnal over the timeframe of the project, successful completion of the TAIN project will highlight Diurnal’s capabilities in orphan drug development”
Melanie Goward, Finance Wales stated
“We are delighted that Diurnal and its partners, with support from the Welsh Government, have been awarded this important grant that will complement and build on Diurnal’s expertise in the adult hydrocortisone replacement field’”