Diurnal Group PLC First Patient Dosed in US Infacort Clinical Trial (1101I)
15 June 2017 - 4:00PM
UK Regulatory
TIDMDNL
RNS Number : 1101I
Diurnal Group PLC
15 June 2017
15 June 2017
Diurnal Group plc
("Diurnal" or the "Company")
First patient dosed in food matrix compatibility study intended
to form part of US Phase III registration package for lead product,
Infacort(R)
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that it has successfully dosed the first
patient in a food matrix compatibility study for Infacort(R) in
healthy volunteers. This study supports the planned US registration
package for Infacort(R) for the treatment of paediatric adrenal
insufficiency (AI). As previously announced, Diurnal will initiate
the pivotal Phase III clinical trial in the target paediatric
population (0-16 years of age) following final confirmation on the
trial design from the US Food and Drug Administration (FDA).
The food matrix compatibility study is a single centre,
open--label, randomised, single dose crossover study in 18 healthy
adult subjects (EudraCT NUMBER: 2016-001388-36). The primary
objective of the study is to evaluate the bioavailability of
Infacort(R) multiparticulate granules administered as sprinkles
with soft food or yoghurt compared with direct administration to
the back of the mouth. The secondary objective is to assess the
safety and tolerability of Infacort(R) throughout the study.
AI is a condition characterised by deficiency in cortisol, an
essential hormone in regulating metabolism and the response to
stress. AI has been identified as an orphan disease in the US where
there are estimated to be approximately 4,500 sufferers under the
age of 16. Untreated, the disease is associated with significant
morbidity and increased mortality. Currently there are no available
preparations of hydrocortisone (the synthetic version of cortisol)
in the US specifically designed to treat these young patients.
Infacort(R) has the potential to be the first pharmaceutically
defined dose and consistent formulation of hydrocortisone designed
specifically for children.
In the US, Diurnal holds Orphan Drug Designation for Infacort(R)
in paediatric AI, which affords seven years' market exclusivity
post New Drug Application approval. A robust patent portfolio
provides protection for Infacort(R) to 2034, which significantly
bolsters the Company's exclusivity position.
Martin Whitaker, CEO of Diurnal, commented:
"We are excited to have dosed the first patient in this food
matrix compatibility study. This is an important prerequisite to
the planned US pivotal Phase III clinical trial for Infacort(R) in
the treatment of paediatric adrenal insufficiency, for which we
await final confirmation on the study design with the FDA before
commencing. We believe the US will be an important market for
Infacort(R) where it has the potential to address a significant
unmet need for children with adrenal insufficiency who are not
being treated satisfactorily."
In Europe, Infacort(R) is currently under regulatory review in
the European Medicines Agency (EMA) for the treatment of paediatric
AI having announced the successful completion of the European
pivotal trial in July 2016, with approval anticipated in late
2017.
For further information, please visit www.diurnal.co.uk
or contact:
+44 (0)20 3727
Diurnal Group plc 1000
Martin Whitaker, Chief Executive
Officer
Richard Bungay, Chief Financial
Officer
Numis Securities Ltd (Nominated +44 (0)20 7260
Adviser) 1000
Nominated Adviser: Michael Meade,
Freddie Barnfield, Paul Gillam
Corporate Broking: James Black
Panmure Gordon (UK) Limited (Joint +44 (0) 20 7886
Broker) 2500
Corporate Finance: Freddy Crossley
/ Duncan Monteith
Corporate Broking: Tom Salvesen
+44 (0)20 3727
FTI Consulting 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Adrenal Insufficiency
Adrenal Insufficiency (AI) is a condition characterised by
deficiency in cortisol, an essential hormone in regulating
metabolism and the response to stress. AI has been identified as an
orphan disease in the US where there are estimated to be
approximately 4,500 sufferers younger than the age of sixteen, with
a similar number in Europe. Currently there are no available
hydrocortisone preparations in the US or Europe specifically
designed to treat these young patients. These children are often
administered compounded adult tablets or other unlicensed products.
Poor control of disease can result in precocious puberty in young
children, virilisation in girls and chronic fatigue leading to a
poor quality of life in adulthood resulting in increased morbidity
and mortality.
About Infacort(R)
Infacort(R) represents the first preparation of hydrocortisone
specifically designed for use in children suffering from AI. It is
a patented, immediate-release, oral, paediatric formulation of
hydrocortisone that allows for age-appropriate dosing in children.
This therapeutic approach has the potential to help young patients
less than sixteen years of age in the US suffering from diseases
due to cortisol deficiency including AI and Congenital Adrenal
Hyperplasia (CAH). AI requires life-long treatment and Diurnal's
novel approach to product development has the potential to
significantly improve these young patients' lives. Diurnal has
already submitted for market authorisation in Europe to the
European Medicines Agency via the Paediatric Use Marketing
Authorisation (PUMA) route and anticipates approval in late
2017.
About Diurnal Group plc
Founded in 2004, Diurnal is a UK-based specialty pharma company
developing high quality products for the global market for the
life-long treatment of chronic endocrine conditions, including CAH
and AI. Its expertise and innovative research activities focus on
circadian-based endocrinology to yield novel product candidates in
the rare and chronic endocrine disease arena.
For further information about Diurnal, please visit
www.diurnal.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
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