Posted on Tuesday, 09/Jun/2020 Posted by michelle

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that a presentation, entitled ‘A Phase 3 Study of a Modified-Release Hydrocortisone in the Treatment of Congenital Adrenal Hyperplasia,’ will be presented by Deborah P. Merke, MD, MS, from NIH Clinical Center and NICHD, Bethesda, MD, USA, at ENDO Online 2020.

The presentation will focus on data from Diurnal’s Phase 3 clinical trial of Chronocort® (modified release hydrocortisone) for the treatment of congenital adrenal hyperplasia (CAH) in adults, the largest interventional study conducted to date in this patient population. The Phase 3 data forms the basis for Diurnal’s Marketing Authorisation Application (MAA) for Chronocort® in Europe. The MAA is currently under review following submission to the European Medicines Agency (EMA) in December 2019 and validation in April 2020. Diurnal is targeting recommendation for approval of Chronocort® by the EMA in Q1 2021.

The presentation is part of the on-demand programme during the online conference, which will be available to view for free from 11:00 EDT on Monday 8 June 2020 until Monday 22 June 2020. To register for ENDO Online 2020 to view the presentation, please visit www.endocrine.org/meetings-and-events/endo-online-2020.

The details of the presentation are as follows:

Abstract Number:     OR25-02
Title:                         A Phase 3 Study of a Modified-Release Hydrocortisone in the Treatment of Congenital Adrenal Hyperplasia
Day/Date:                 Available from 11:00 EDT on Monday 8 June to Monday 22 June
Session:                    Adrenal Medicine – Clinical Applications and New Therapies
Session Type:           Oral Session

For further information, please visit www.diurnal.co.uk or contact:

Diurnal Group plc +44 (0)20 3727 1000
Martin Whitaker, Chief Executive Officer 
Richard Bungay, Chief Financial Officer 

Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns

FTI Consulting +44 (0)20 3727 1000
Simon Conway 
Victoria Foster Mitchell

Notes to Editors

About ENDO Online 2020
ENDO Online 2020’s comprehensive program offers attendees the opportunity to learn about the latest developments in hormone science and medicine from renowned investigators, expert clinicians, and educators from all over the world. Join ENDO Online 2020 for a mixture of live and on-demand content and stay at the forefront of scientific discovery and high-quality patient care.

About Chronocort®
Chronocort® 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® is currently under review by the EMA. Chronocort® 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 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 steroids (hydrocortisone, dexamethasone and prednisolone) 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, 17,000 in the US, with over 400,000 in the rest of the world.

About Diurnal Group plc
Founded in 2004, Diurnal is a UK-headquartered, European 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:  June 2020            Code: CORP-USA-0003