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DIURNAL REPORTS POSITIVE HEADLINE DATA FROM EUROPEAN INFACORT PHASE III PIVOTAL STUDY

DIURNAL LTD BASED AT CARDIFF MEDICENTRE REPORTS POSITIVE HEADLINE DATA FROM EUROPEAN INFACORT® PHASE III PIVOTAL STUDY

 


Primary endpoint met, with Infacort® treatment achieving target cortisol levels in children aged less than six years

Major breakthrough in paediatric Adrenal Insufficiency, a condition of high unmet medical need with no currently licensed formulation for young children


European market authorisation anticipated in late 2017

Infacort® is the first Diurnal product candidate to complete a registration study, a major milestone towards building a proprietary endocrinology franchise

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces, ahead of schedule, positive headline data from the pivotal study for Infacort® in Europe for paediatric Adrenal Insufficiency (AI).

AI is characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. It is identified as a rare disease in Europe where there are estimated to be approximately 4,000 sufferers younger than the age of six. Untreated, the disease is associated with significant morbidity. Currently there are no licensed hydrocortisone (the synthetic version of cortisol) preparations in Europe specifically designed to treat these young patients. Infacort® is on target to be the first pharmaceutically defined dose and consistent formulation of hydrocortisone designed specifically for children.

The Phase III trial was designed in agreement with the European Medicines Agency (EMA) and conducted in a total of 24 subjects before their sixth birthday, requiring replacement therapy for AI due to Congenital Adrenal Hyperplasia (CAH), primary adrenal failure or hypopituitarism.

Initial analysis of the results confirms that the study met its primary endpoint, demonstrating a statistically significant (p<0.0001) increase in cortisol values following administration of Infacort® compared to the pre-dose values. No serious adverse events were reported. A full evaluation of the data is underway and the results of this comprehensive analysis are expected later this quarter.

The EMA has already approved a Paediatric Investigation Plan (PIP) for Infacort®, setting out the regulatory pathway to market authorisation via the Paediatric Use Marketing Authorisation (PUMA) route. Diurnal is on track to submit this regulatory dossier to the EMA around the end of 2016. If approved, Infacort® has the potential to be the first licensed treatment in Europe for AI (including CAH) specifically designed for use in children. Diurnal anticipates market authorisation in late 2017.

Martin Whitaker, CEO of Diurnal, commented:
“We are pleased to announce the completion of treatment in this pivotal study and look forward to the announcement of the full clinical data package shortly. 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. With Infacort® now ready for regulatory filing later this year and anticipated market authorisation in late 2017, we have taken a major step towards realisation of our vision.”

Following US Food and Drug Administration (FDA) feedback, Diurnal will be commencing the US registration programme for Infacort® in 2016.

Published on Thu, 15th Sep 2016

 
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