Cardiff, UK - Diurnal Limited, a spin-out company from the University of Sheffield, today announced positive results from its Infacort 001 clinical study. The study in 16 healthy adult volunteers, forms part of the company's Infacort® development programme to develop a paediatric treatment for children under 6 years of age suffering from the rare disease Adrenal Insufficiency.
The trial successfully met its primary objective of demonstrating Infacort® bioequivalence to 10mg hydrocortisone tablets in healthy adult volunteers. Infacort® was shown to be safe, well-tolerated and to be of neutral taste.
Infacort® is a paediatric hydrocortisone product being developed by Diurnal and its partners under the European Commission funded collaborative research Framework 7 Programme ' "Treatment of Adrenal Insufficiency in Neonates (TAIN)". The programme will, for the first time, create a regulatory-approved paediatric version of hydrocortisone.
About Adrenal Insufficiency in Children
Adrenal Insufficiency is a rare disorder that prevents the body from producing sufficient amounts of the essential hormone cortisol. Hydrocortisone is a glucocorticoid hormone used as a replacement therapy for the treatment of Adrenal Insufficiency. The problem of effective hydrocortisone replacement is particularly acute among young patients (neonates and infants) for whom no licensed therapy exists. Current therapy requires adaption of adult formulations through, amongst other methods, crushing tablets. This is problematic and gives variable and inaccurate dosing as crushed tablets are relatively insoluble, provide an unpredictable pharmacokinetic profile, have no established stability, and are inconvenient for clinicians and parents. Current hydrocortisone preparations put the neonate at risk over and under treatment with potential long term health consequences including obesity, ill health and sudden death.
Infacort® is an immediate release hydrocortisone granule preparation specifically designed for use in children under 6 years of age. Infacort® is being developed under a Paediatric Investigation Plan approved by the European Medicines Agency (EMA) EMEA-001283-PIP01-12. Infacort® has been designed with taste masking excipients that are acceptable for paedriatric use and in a variety of dosage units to give maximum flexibility to clinicians to tailor the treatment to the child.
The TAIN Consortium involves European leaders in drug development, neonatology and paediatric pharmacology. The approved Paediatric Investigation Plan from the EMA will enable clinical trials to be carried out to provide sufficient evidence of safety and efficacy for Infacort® to allow submission of a Paediatric Use Medicines Authorisation (PUMA). The project also aims to raise awareness of Adrenal Insufficiency to maximise its positive impact for patients, parents and clinicians. For further information see www.tain-project.org.
Martin Whitaker, Chief Executive Officer at Diurnal Ltd, commented:
"These results for Infacort® were excellent and hit all the set target success parameters. We hope to progress to Phase 3 studies rapidly. This is a very exciting time for the whole of the Diurnal team."
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