11th Jul 2016 06:45
LONDON (Alliance News) - Diurnal Group PLC Monday said it has received positive data from a pivotal study for Infacort for paediatric adrenal insufficiency and said it expects to secure market authorisation in Europe late next year.
FTSE 250-listed IP Group PLC, the developer of intellectual property-based businesses, released a statement noting Diurnal's trial as it holds a 45% stake in the company.
The European Phase III study on Infacort has been completed ahead of schedule and achieved its primary endpoint of targeting cortisol levels in children under the age of six.
Adrenal insufficiency is characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. Diurnal said the disease is rare in Europe with around 4,000 suffers under the age of six estimated to have the disease.
There is no licensed treatments in Europe for hydrocortisone, the synthetic version of cortisol, that are designed to treat younger patients, and Diurnal said Infacort is on target to be the first pharmaceutically defined dose and consistent formulation of hydrocortisone designed specifically for children.
Diurnal said it will submit the next regulatory document to the Paediatric Use Marketing Authorisation by the end of 2016. If approved, Infacort could then have the potential to become the first treatment of its kind in Europe, with market authorisation expected in "late 2017".
By Joshua Warner; [email protected]; @JoshAlliance
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