Diurnal reports positive headline data from pivotal Phase III trial of Infacort to treat paediatric AI

UK-based pharmaceutical company Diurnal has reported positive headline data from its pivotal study of Infacort in Europe to treat paediatric adrenal insufficiency (AI).

Infacort is a patented, immediate-release, oral, paediatric formulation of hydrocortisone that is intended to be used as age-appropriate dosing in children.

The pivotal Phase III trial was an open-label study and had fulfilled its primary focus of achieving improvement in cortisol values after being administered of Infacort when compared to the pre-dose values.

Designed in agreement with the European Medicines Agency (EMA), the trial involved 24 patients who were aged below six and required replacement therapy for AI due to Congenital Adrenal Hyperplasia (CAH), primary adrenal failure or hypopituitarism.

Diurnal CEO Martin Whitaker said: “The initial results of this pivotal study are very exciting as Infacort has the potential to address a significant unmet need for children with Adrenal Insufficiency who are not being treated satisfactorily.

“This marks a significant developmental milestone for Diurnal as we move towards building a proprietary endocrinology franchise based on Infacort and our second product, Chronocort, which is in Phase III trials in Europe for adult CAH.”

AI is triggered by the deficiency in cortisol, an essential hormone regulating metabolism, as well as the response to stress.

Approximately 4,000 children younger than the age of six are afflicted with this disease in Europe.

Infacort makes a therapeutic approach to treat cortisol deficiency including adrenal insufficiency and congenital adrenal hyperplasia.