University spin-out overcomes major hurdle

FUSION IP, which commercialises research from universities, has today announced that its portfolio company, Diurnal, a spin-out from the University of Sheffield, has overcome a major regulatory hurdle.

Cardiff-based Diurnal has received approval for a Paediatric Investigation Plan from the European Medicines Agency (EMA). This is 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).

Peter Grant, operations director of Fusion IP, said: “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.”

Chronocort, Diurnal’s most advanced product, has been developed to be used by adults suffering from cortisol deficiency, whilst Infacort will be developed for the treatment of children under 6 years old suffering a similar inability to produce cortisol.

Fusion owns a 43% shareholding in Diurnal.