TIDMDNL
RNS Number : 4804N
Diurnal Group PLC
01 June 2022
1 June 2022
Diurnal Group plc
("Diurnal" or the "Company")
First patient dosed in pivotal Phase 3 CONnECT clinical trial
for US and Japanese markets
Headline data from CONnECT is anticipated in 2024
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that the first patient has been dosed in its
Phase 3 pivotal clinical trial of hydrocortisone modified-release
hard capsules (DNL-0200 - approved in Europe and the UK under the
commercial name Efmody(R) ) for adults with congenital adrenal
hyperplasia (CAH).
The pivotal Phase 3 randomised, double-blind, active-controlled,
clinical trial, known as CONnECT, is evaluating the efficacy,
safety and tolerability of modified-release hydrocortisone compared
with immediate-release hydrocortisone replacement therapy in
participants aged 16-years and over with CAH. The pivotal study for
key US and Japan markets worth together in excess of $100m per
annum will recruit up to 150 subjects with CAH who will be treated
for a period of 52 weeks in centres across Japan, the US, France,
and Turkey. The study is anticipated to take up to one year to
recruit all patients, with subsequent data readout anticipated in
2024. The study is being conducted under a Special Protocol
Assessment (SPA) that has been agreed with the US FDA. The SPA
provides agreement that the Phase 3 trial design adequately
addresses objectives that would support the regulatory submission
for drug approval.
DNL-0200 is a preparation of hydrocortisone that has been
specifically designed for patients with diseases of cortisol
deficiency such as CAH and is currently approved as the only near
physiological cortisol replacement treatment for CAH in Europe and
the UK.
Richard Bungay, Interim Chief Executive Officer of Diurnal,
commented:
"I am delighted that we have dosed the first patient in this
important clinical trial. CONnECT builds on knowledge gained from
our European study for DNL-0200, to date the largest ever completed
study in CAH, and as the first blinded study, CONnECT should prove
to be the definitive evidence for optimal treatment of patients
with CAH."
This is a business press release containing financial
information and/or data for the benefit of shareholders and
potential investors. Data are included to allow informed investment
decisions.
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
Richard Bungay, Interim Chief Executive Officer
Panmure Gordon (UK) Limited (Nominated Adviser +44 (0)20 7886
and Joint Corporate Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: Rupert Dearden
Stifel Nicolaus Europe Limited (Joint Corporate +44 (0) 20 7710
Broker) 7600
Healthcare Investment Banking: Nicholas Moore,
Samira Essebiyea, William Palmer-Brown
Corporate Broking: Nick Adams, Nick Harland
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Alex Davis
+44 (0) 173 782
Vane Percy & Roberts (Medical Communications) 1890
Simon Vane Percy
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
(steroid) preparations 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 between 1 in 10,000 and 1 in
15,000 individuals globally.
About DNL-0200 (modified-release hydrocortisone)
DNL-0200 is a modified-release oral formulation of
hydrocortisone that is designed to match the normal serum levels of
the endogenous cortisol circadian rhythm by replicating the normal
overnight rise in serum cortisol levels and providing physiological
levels upon waking. It is anticipated that providing a near
physiological circadian rhythm of cortisol will improve health
outcomes in patients with diseases of cortisol deficiency such as
CAH and adrenal insufficiency (AI) who are receiving glucocorticoid
replacement therapy. DNL-0200 has been extensively studied in 239
human subjects who have taken part in clinical trials in Europe and
the US.
DNL-0200 (commercial name Efmody(R) ) was approved by the
European Commission in May 2021 and by the UK Medicines and
Healthcare Regulatory Agency (MHRA) in July 2021 as a replacement
treatment in patients suffering from the genetic condition
congenital adrenal hyperplasia (CAH). Efmody(R) is commercially
available in both Europe and the UK for the treatment of
adolescents (greater than 12 years old) and adults with CAH.
The human medicine European Public Assessment Report (EPAR) for
Efmody(R) can be viewed here and the Summary of Product
Characteristics (SmPC) here .
About Diurnal Group plc
Diurnal Group plc is a European, UK-headquartered, specialty
pharmaceutical company dedicated to developing hormone therapeutics
to aid lifelong treatment for rare and chronic endocrine
conditions, including congenital adrenal hyperplasia, adrenal
insufficiency, hypogonadism and hypothyroidism. 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.com
Date of Preparation: May 2022 Code: CORP-GLO-0038
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