Diurnal Group notes publication of Infacort study

Speciality pharmaceutical company Diurnal Group announced the publication of data from its pivotal Phase III trial for its lead product ‘Infacort’ in Clinical Endocrinology on Friday.

The AIM-traded firm said the paper, titled ‘Absorption and tolerability of taste-masked hydrocortisone granules in neonates, infants and children under 6 years of age with adrenal insufficiency’, was published on an open access basis.

An oral presentation of the data by one of the investigators, Dr. Oliver Blankenstein, would take place on 16 September at the joint meeting of the European Society of Paediatric Endocrinology and the Pediatric Endocrine Society in Washington DC.

“Adrenal Insufficiency (AI) in children is currently treated by crushing or compounding adult preparations of hydrocortisone with no regulated dose or consistent formulation for children,” the Diurnal board explained in its statement.

“Infacort, Diurnal's most clinically advanced product, is specifically designed to provide the first regulated, consistent preparation of hydrocortisone to ensure efficacy and safety and ease of use for children suffering from AI, including the related disease, Congenital Adrenal Hyperplasia (CAH).”

Infacort was currently under regulatory review by the European Medicines Agency (EMA), Diurnal said, and it anticipated receiving recommendation for approval in Europe towards the end of 2017.

“The US is also expected to be a major territory for sales of Infacort and the company continues to progress discussions with the US Food and Drug Administration (FDA) regarding the requirements for the registration programme in the US.”