Fusion IP overcomes European hurdle

The Sheffield University spin-out company, which is based in Cardiff, received approval for a Paediatric Investigation Plan from the European Medicines Agency for a new formulation of hydrocortisone called Infacort.

Diurnal is developing a new approach to drug delivery that will help children under six years old suffering from reduced levels of the key hormone cortisol (hydrocortisone).

The firm’s lead drug, Chronocort, which has been developed to be used by adults suffering from cortisol deficiency, is currently in a phase two of the study at the National Institute of Health in the US.

Fusion IP said that under the 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 to the European Medicines Agency by the end of 2015 and its subsequent use in patients.

Fusion owns a 43 per cent shareholding in Diurnal.

Peter Grant, operations director of Fusion IP, said: “Infacort now has a clear route to obtaining market authorisation in Europe.”