TIDMDNL
RNS Number : 6304N
Diurnal Group PLC
02 February 2021
02 February 2021
Diurnal Group plc
("Diurnal" or the "Company")
Chronocort(R) Phase 3 and Safety Extension Study results
published in JCEM
Peer-reviewed data from largest ever completed interventional
clinical trial in CAH
Authors conclude that Chronocort(R) provides a well-tolerated
and practical twice-daily treatment regimen for CAH
Data also forms part of EMA and MHRA submissions with
anticipated positive regulatory opinion in Q1 2021
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that the endocrinologist-focused Journal of
Clinical Endocrinology and Metabolism ("JCEM") has today published
the peer-reviewed results of the Company's Phase 3 clinical trial
and extension study for Chronocort(R) (hydrocortisone
modified-release hard capsules) in patients with the rare condition
congenital adrenal hyperplasia (CAH).
The Company's Phase 3 study was conducted in a total of 122
patients enrolled across 11 clinical sites, the largest ever
interventional clinical trial completed in CAH patients. Data are
also presented from an open-label safety extension study for
patients completing treatment in the Phase 3 study. These data
assessed the impact of treatment with Chronocort(R) over a further
period of 18 months. A significant proportion of patients eligible
to enter the follow-on study did so, and patient retention rates in
this study remain high.
As previously announced, the Phase 3 study results published by
the JCEM found that although the standard-deviation-score-focused
primary endpoint of the study was missed, Chronocort(R) improved
morning and early afternoon biochemical control for adults with CAH
over standard glucocorticoid therapy. In the safety extension
study, biochemical control was sustained for 18 months on median
hydrocortisone doses in the range recommended for cortisol
replacement therapy and lower than glucocorticoid doses normally
used in the treatment of CAH. The manuscript concludes that
Chronocort(R) provides a well-tolerated and practical twice-daily
treatment regimen for CAH in adults, due to a deficiency of
21-hydroxylase.
The JCEM advanced article, entitled "Modified-release
Hydrocortisone in Congenital Adrenal Hyperplasia" can be accessed
here:
https://academic.oup.com/jcem/article-lookup/doi/10.1210/clinem/dgab051
Chronocort(R) is a modified-release preparation of
hydrocortisone that is under review by the European Medicines
Agency (EMA) and the UK Medicines and Healthcare products
Regulatory Agency (MHRA), with the submissions based on the Phase 3
clinical trial and safety extension study data. If regulatory
review is successful, marketing authorisation opinions for
Chronocort(R) approval in the European Economic Area (including
Northern Ireland) and Great Britain are anticipated during Q1
2021.
Data from the JCEM manuscript, the Chronocort(R) Phase 3
clinical trial and extension study will be included in the
Company's analyst presentation, on Tuesday 23 February 2021 for the
financial results for the six months ended 31 December 2020, which
will be available on the Company's website shortly thereafter.
Professor Richard Ross, a founding Director of Diurnal and Chief
Scientific Officer, commented:
"The team at Diurnal and I are delighted to have our data from
the Chronocort(R) Phase 3 clinical trial and safety extension study
published in the prestigious Journal of Clinical Endocrinology and
Metabolism. These results confirm the effectiveness of
Chronocort(R) , which provides a much needed, well-tolerated and
practical twice-daily treatment regimen for adults with CAH due to
a deficiency of 21-hydroxylase."
Martin Whitaker, Chief Executive Officer of Diurnal,
commented:
"Today's peer-reviewed publication in the JCEM is a significant
milestone and discloses the full data set behind our European
pivotal clinical study for Chronocort(R) as a potential treatment
for CAH. This data has also formed part of our submissions to the
EMA and MHRA, where we anticipate positive regulatory opinion
during this quarter. If approved, Chronocort(R) could be a valuable
treatment option for CAH patients across Europe, a rare condition
that we estimate affects a total of approximately 41,000
people."
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 Sole Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: Rupert Dearden
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
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 issues during sexual
development 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 glucocorticoid
(steroids including hydrocortisone, dexamethasone, prednisolone and
prednisone in the US) with no standard treatment regimen.
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 41,000 patients in
Europe, with over 400,000 in the rest of the world.
About Chronocort(R)
Chronocort(R) is a modified-release preparation of
hydrocortisone that has been specifically 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 and adolescents. Chronocort(R)
has been extensively studied in human subjects 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 and
the US.
About Diurnal Group plc
Founded in 2004, Diurnal is a UK-headquartered, European
specialty pharma company developing hormone therapeutics for the
global market for the life-long treatment of chronic endocrine
conditions, including congenital adrenal hyperplasia, adrenal
insufficiency and hypogonadism. 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: February 2021 Code: CORP-GB-0100
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