Diurnal Group PLC Completion of patient enrolment in EU Phase III (5185E)
February 12 2018 - 1:00AM
UK Regulatory
TIDMDNL
RNS Number : 5185E
Diurnal Group PLC
12 February 2018
12 February 2018
Diurnal Group plc
("Diurnal" or the "Company")
Completion of patient enrolment in European pivotal Phase III
clinical study of Chronocort(R) for the treatment of Congenital
Adrenal Hyperplasia
Study scheduled to complete in Q3 2018; potential market
authorisation in Europe in 2020
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that it has successfully completed patient
enrolment for its European pivotal Phase III clinical trial of
Chronocort(R) (modified release hydrocortisone) for the treatment
of Congenital Adrenal Hyperplasia (CAH) in adults.
The Phase III trial is an open label study in which adult
patients with CAH, currently treated with a single or combination
of generic steroids (standard-of-care), are randomised to either
receive Chronocort(R) on a twice daily "toothbrush" regimen or
continue on their standard-of-care regimen. The primary endpoint of
the trial is the control of androgens (sex hormones) at six months
on equivalent or lower total daily dose of steroid when treated
with Chronocort(R) compared to standard-of-care treatment. This
primary endpoint is similar to an endpoint previously reported in
the Phase II clinical trial, where the data showed a significant
reduction in the morning levels of 17-hydroxyprogesterone (the main
androgen) in patients after six months on Chronocort(R) (median
70nmol/l vs 5.65nmol/l p= 0.014), with 94% of values in the normal
or optimal range compared to 31% before Chronocort(R) therapy[i].
Secondary endpoints will include an assessment of fatigue levels
and the relative effect of Chronocort(R) on body mass index and
bone turnover, all of which are indicative of clinical benefits.
Headline data from this trial is expected in Q3 2018 and, if
positive, could lead to potential market authorisation in Europe in
2020.
CAH is an orphan condition usually caused by deficiency of the
enzyme 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 has been associated with increased mortality, infertility,
reduced quality of life and cardiovascular morbidity. Sufferers,
even if treated, remain at risk of death through an adrenal
crisis.
Approximately two-thirds of CAH patients are estimated to have
poor disease control, leading to elevated androgen levels. The
condition is estimated to affect approximately 64,000 patients in
Europe (47,000) and the US (17,000), with over 400,000 in the rest
of the world. Current therapy for CAH uses a variety of generic
steroids (hydrocortisone, dexamethasone and prednisolone) which, at
best, adequately treat approximately one-third of CAH patients.
Other therapies being developed are at an early stage of
development and not expected to receive approval in the
short-term.
Chronocort(R) has been granted Orphan Drug Designations in
Europe and the US in the treatment of CAH, which, if confirmed at
marketing authorisation, provides market exclusivity for 10 years
in Europe and seven years in the US post market authorisation.
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"Chronocort(R) provides a drug release profile that has been
designed to mimic the body's natural cortisol circadian rhythm more
closely and therefore has the potential to achieve better CAH
disease control for patients than current treatment options. As the
majority of CAH patients have poor disease control, we believe
Chronocort(R) offers the potential to significantly improve many of
the symptoms of this debilitating condition. We look forward to
reporting headline data from this trial in 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
About Chronocort(R)
Chronocort(R) is a modified release preparation of
hydrocortisone (the synthetic form of cortisol) 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). The first planned
indication for Chronocort(R) is CAH. Chronocort(R) has completed
three Phase I trials in 2011, 2012 and 2015 and a Phase II trial in
CAH patients in 2014.
Chronocort(R) Phase II trial
Data from the Chronocort(R) Phase II trial demonstrated that the
trial met its primary endpoint of fully characterising the
pharmacokinetic profile of Chronocort(R) in 16 male and female
adult subjects with CAH. The results showed Chronocort(R) provides
circadian levels of the stress hormone, cortisol, similar to the
healthy population mimicking the overnight rise in cortisol levels,
such that patients wake with a normal cortisol level.
In addition, the secondary objective of examining the effect of
Chronocort(R) on the morning biochemical efficacy markers of the
disease showed a significant reduction in the morning levels of
17-hydroxyprogesterone (the main androgen) in patients after six
months on Chronocort (median 70nmol/l vs 5.65nmol/l p= 0.014) with
94% of values in the normal or optimal range compared to 31% before
Chronocort therapy(i) . Chronocort(R) was well-tolerated during the
six-month trial. The trial was reported in the Journal of Clinical
Endocrinology and Metabolism (Mallappa et al JCEM 2014).
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
[i] Diurnal Data on File
This information is provided by RNS
The company news service from the London Stock Exchange
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