Diurnal Group PLC Positive results from Alkindi food matrix study (2857B)
January 09 2018 - 1:00AM
UK Regulatory
TIDMDNL
RNS Number : 2857B
Diurnal Group PLC
09 January 2018
9 January 2018
Diurnal Group plc
("Diurnal" or the "Company")
Diurnal reports positive results from food matrix compatibility
study intended to form part of US registration package for
Alkindi(R)
Results show Alkindi(R) retains bioavailability in adults when
administered with food
Dosage shown to be well tolerated
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces positive data from the food matrix
compatibility study for Alkindi(R) (development programme name:
Infacort(R) ; hydrocortisone granules in capsules for opening) in
healthy adult volunteers. This study supports the planned US
registration package for Alkindi(R) for the treatment of paediatric
adrenal insufficiency (AI). The Company has opened an IND for
Alkindi(R) and, following advice from the US Food and Drug
Administration (FDA), will be in a position to start the next study
in the registration programme, a bioequivalence study in healthy
adult volunteers, during H1 2018.
The food matrix compatibility study was a single centre,
open--label, randomised, single dose crossover study in 18 healthy
adult subjects (EudraCT NUMBER: 2016-001388-36; ClinicalTrials.gov
Identifier: NCT03178214). The primary objective of the study was to
evaluate the bioavailability of Alkindi(R) multi-particulate
granules administered as sprinkles onto soft food or yoghurt
compared with direct administration to the back of the mouth. The
secondary objective was to assess the safety and tolerability of
Alkindi(R) throughout the study.
The results of the study confirm that the pharmacokinetics of
Alkindi(R) when sprinkled onto soft food or yoghurt are equivalent
to Alkindi(R) administered directly. There were no adverse events
and Alkindi(R) was well tolerated.
Paediatric AI is a condition characterised by deficiency in
cortisol, an essential hormone in regulating metabolism and the
response to stress. Paediatric 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.
Alkindi(R) has the potential to be the first pharmaceutically
defined dose and consistent formulation of hydrocortisone (the
synthetic version of cortisol) designed specifically for
children.
In the US, Diurnal holds Orphan Drug Designation for Alkindi(R)
for paediatric AI, which affords seven years' market exclusivity
post New Drug Application approval. A robust, granted, patent
portfolio provides protection for Alkindi(R) to 2034, which
significantly bolsters the Company's exclusivity position.
Martin Whitaker, CEO of Diurnal, commented:
"We are pleased to announce positive data for this important
prerequisite to support the planned Alkindi(R) registration
programme in the US. We believe the US will be an important market
for Alkindi(R) where it has the potential to address a significant
unmet need for children with adrenal insufficiency who are not
being treated satisfactorily and we continue our discussions with
the FDA to finalise additional requirements for the registration
package for the product."
In Europe, the Company has received a positive opinion for
approval for Alkindi(R) from the European Medicines Agency and the
final decision on the paediatric use market authorisation (PUMA)
from the European Commission is anticipated in February 2018. The
European launch of Alkindi(R) is expected to follow in Q2,
2018.
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,
Paul Gillam, Freddie Barnfield,
Corporate Broking: James Black
Panmure Gordon (UK) Limited (Joint +44 (0) 20 7886
Broker) 2500
Corporate Finance: Freddy Crossley
Corporate Broking: Tom Salvesen
+44 (0)20 3727
FTI Consulting 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Alkindi(R)
Alkindi(R) represents the first preparation of hydrocortisone
specifically designed for use in children suffering from paediatric
AI. Alkindi(R) is a patented, oral, immediate-release paediatric
formulation of hydrocortisone granules in capsules for opening 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 paediatric 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.
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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