TIDMDNL
RNS Number : 0408K
Diurnal Group PLC
11 December 2018
11 December 2018
Diurnal Group plc
("Diurnal" or the "Company")
Regulatory package for Chronocort(R) submitted for Scientific
Advice in Europe
Further analysis of data from European Chronocort(R) Phase III
and safety extension study demonstrate significant benefits for
patients sustained for at least 12 months
Analyst meeting to discuss the data to take place today
Subject to the outcome of the Scientific Advice request, Diurnal
anticipates filing a Marketing Authorisation Application for
Chronocort(R) in Q4 2019
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, today announces that it has submitted a regulatory
package requesting Scientific Advice to the European Medicines
Agency (EMA) for Chronocort(R) (modified release hydrocortisone)
based on detailed analysis of data from the largest ever clinical
trial programme in congenital adrenal hyperplasia (CAH). Subject to
a favourable outcome from the request, Diurnal anticipates
submitting a Marketing Authorisation Application (MAA) for
Chronocort(R) in Q4 2019, including a potential application for
Orphan Drug Designation in the treatment of CAH.
Following the Company's announcement on 8 October 2018 that
Chronocort(R) had not met the primary endpoint in its European
Phase III trial for the treatment of congenital adrenal hyperplasia
(CAH) based on an analysis of the primary endpoint, Diurnal has
undertaken further post-hoc analysis of the clinical trial data,
based upon methods previously discussed with the EMA, identifying
clinically important differences between Chronocort(R) and the
control arm of the trial, in particular:
-- Using the primary outcome measure, Chronocort(R) achieved
statistically significantly better control of the androgen 17-OHP
during the period 0700-1500 when androgens are typically high
-- Chronocort(R) achieved statistically significantly lower
overall levels of the androgen 17-OHP over 24 hours using an area
under the curve (AUC) analysis.
In addition, the following benefits were seen with Chronocort(R)
compared to the standard-of-care arm:
-- Levels of the androgen 17-OHP were less variable on Chronocort(R) over 24 hours;
-- Androgen control (both 17-OHP and A4) was achieved on a lower
dose of steroid in the Chronocort(R) arm;
-- More episodes of unexpected therapeutic benefit were seen with Chronocort(R) ;
-- Fewer sick day rules, where patients have to supplement their
daily replacement treatment with additional steroid doses, were
seen with Chronocort(R) ;
-- No adrenal crises were seen with Chronocort(R)
An interim analysis of data from the ongoing safety extension
study in Europe, an open-label, 'roll-over' trial in which patients
from the Phase III trial have continued Chronocort(R) treatment,
also highlighted sustained benefit for patients treated with
Chronocort(R) , in particular:
-- Androgen control (17-OHP and A4) was maintained over the period, up to 24 months;
-- There were further steroid dose reductions of approximately
20% over the period of treatment.
Diurnal will hold an analyst meeting today to discuss the
challenges and current treatment options for CAH, and the current
situation with Chronocort(R) . The meeting will be led by Martin
Whitaker, Chief Executive Officer of Diurnal, with speakers
including Professor John Newell-Price, an investigator in the
clinical trials of Chronocort(R) , and Dr. John Porter, Medical
Director of Diurnal.
A copy of the presentation will be made available on Diurnal's
website
(https://www.diurnal.co.uk/non-healthcare-professionals/investors/shareholder-information/)
following the analyst meeting.
Professor John Newell-Price MA PhD FRCP, Department of Oncology
& Metabolism, Chair of Endocrinology and Honorary Consultant
Physician, The University of Sheffield, commented:
"Congenital adrenal hyperplasia requires life-long treatment to
replace cortisol and to normalise excessive androgen secretion.
Current hydrocortisone therapies fail to mimic natural circadian
variation and as a result congenital adrenal hyperplasia still
results in significant increased morbidity and mortality for
patients worldwide. New therapies, such as Chronocort(R) , that
have been designed to mimic the body's natural circadian cortisol
release are needed to improve patient outcomes."
Martin Whitaker, Chief Executive Officer of Diurnal, added:
"We have extensive experience of working with patients with
congenital adrenal hyperplasia, including performing the largest
ever clinical trial programme in the condition. Having now
performed a multi-faceted analysis of the complete data set beyond
the pre-specified primary endpoint, we believe the data supports
Chronocort(R) as a potential valuable treatment option for
congenital adrenal hyperplasia. There continues to be a significant
unmet need to improve patient outcomes in this debilitating disease
and we therefore look forward to discussing our data package with
European regulators to agree a pathway forward."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
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
Panmure Gordon (UK) Limited (Nominated Adviser +44 (0) 20 7886
and Joint Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns
+44 (0)20 7894
Cantor Fitzgerald Europe (Joint Broker) 7000
Corporate Finance: Phil Davies, Will Goode,
Michael Boot
Healthcare Equity Sales: Andrew Keith
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Chronocort(R)
Chronocort(R) is a modified release preparation of
hydrocortisone that has been designed to mimic the circadian rhythm
of cortisol when given in a twice-a-day "toothbrush" regimen (last
thing at night before sleep and first thing in the morning on
waking) to control androgen excess and chronic fatigue in patients
with diseases of cortisol deficiency. The first planned indication
for Chronocort(R) is Congenital Adrenal Hyperplasia (CAH) in
adults. Chronocort(R) has been extensively studied in humans having
completed four Phase I trials, a Phase II trial in 16 CAH patients
in the US in 2014, and a Phase III trial in 122 CAH patients in
Europe.
In Europe, Chronocort(R) has been granted Orphan Drug
Designation in the treatment of CAH, which, if confirmed at
marketing authorisation, provides market exclusivity for 10 years.
The market authorisation of Chronocort(R) in Europe is anticipated
in 2020.
About Congenital Adrenal Hyperplasia
Congenital adrenal hyperplasia (CAH) is an orphan condition
caused by deficiency of adrenal enzymes, most commonly
21-hydroxylase. This enzyme is required to produce the adrenal
steroid hormone, cortisol. The block in the cortisol production
pathway causes the over-production of male steroid hormones
(androgens), which are precursors to cortisol. The condition is
congenital (inherited at birth) and affects both sexes. The
cortisol deficiency and over-production of male sex hormones can
lead to increased mortality, infertility and severe development
defects including ambiguous genitalia, premature (precocious)
sexual development and short stature. Sufferers, even if treated,
remain at risk of death through an adrenal crisis.
Current therapy for CAH uses a variety of generic steroids
(hydrocortisone, dexamethasone and prednisolone). Approximately
two-thirds of CAH patients are estimated to have poor disease
control, leading to elevated androgen levels. The condition is
estimated to affect a total of approximately 47,000 patients in
Europe, with over 400,000 in the rest of the world.
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
Congenital Adrenal Hyperplasia and Adrenal Insufficiency. 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
Date of Preparation: December 2018 Code: CH EU-GB-0025
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