Breakthrough for University of Sheffield spin-out business
Sheffield-based Fusion IP (AIM: FIP), the university commercialisation company that turns world-class research into business, has announced a major breakthrough for its portfolio company, Diurnal.
Diurnal, a spin-out from the University of Sheffield, has received approval for a Paediatric Investigation Plan from the European Medicines Agency (EMA) for a new formulation of hydrocortisone – Infacort.
Diurnal is developing a novel approach to drug delivery that will help patients suffering from reduced levels of the key hormone cortisol (hydrocortisone).
Its lead drug Chronocort is currently in a Phase 2 study at the National Institute of Health (US).
Chronocort has already received two related Orphan Drug designations from the European Medicines Yorkshire-based developers Rushbond Group and Advent Developments have partnered up to deliver a new scheme, Bootham Green, developing 38 new homes in Shipton Street, Bootham.
Infacort is being developed by Diurnal and its partners under the EU collaborative research programme – “Treatment of Adrenal Insufficiency in Neonates (TAIN)”. The programme will, for the first time, create a regulatory-approved paediatric version of hydrocortisone.
Peter Grant, operations director of Fusion IP, commented: “This is a major regulatory hurdle that has been successful overcome by Diurnal and the TAIN Consortium. Infacort now has a clear route to obtaining market authorisation in Europe.”
Fusion owns a 43% shareholding in Diurnal.
This was posted in Bdaily's Members' News section by Mark Lane .
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