DNL.L Regulatory News (DNL)

10 February 2022

Diurnal Group plc

("Diurnal" or the "Company")

First patient dosed in Phase 2 clinical trial with modified-release hydrocortisone in adults with adrenal insufficiency

Data from CHAMPAIN European study expected in H2 2022

Positive data could lead to regulatory approval in AI in 2023

 Addressable market seven times larger than CAH

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 2 European clinical trial of modified-release hydrocortisone (DNL-0200 - previously referred to as Chronocort®) for a line extension in adrenal insufficiency (AI). AI represents a significant market opportunity for the Company of approximately $1.9bn across Europe and the UK.

The Phase 2 study will evaluate the efficacy, safety and tolerability of modified-release hydrocortisone versus Plenadren® in AI (CHAMPAIN). The study will recruit up to 50 subjects with primary AI who will be followed for a period of 16 weeks across centres in Germany and the UK.

The CHAMPAIN study is anticipated to take six months to complete with data readout expected in H2 2022. The results of the study will support the Company's discussions with both the European Medicines Agency (EMA) and the UK Medicines and Healthcare Regulatory Agency (MHRA) to seek market authorisations for the product in adult AI in Europe and the UK.

Modified-release hydrocortisone is a preparation of hydrocortisone that has been specifically designed for patients with diseases of cortisol deficiency such as AI and additionally the condition of congenital adrenal hyperplasia (CAH) for which it is approved in Europe and the UK (under the commercial name Efmody®).

AI is an orphan condition caused by inadequate production of steroid hormones in the cortex of the adrenal glands. AI can result in severe fatigue and, if left untreated, adrenal crisis that may be life threatening. AI is estimated to affect 298,000 patients in Europe and the UK.

Martin Whitaker, Chief Executive Officer of Diurnal, commented:

"We are pleased to have dosed our first patient in the CHAMPAIN Phase 2 study for adults with AI as we seek to explore the efficacy of modified-release hydrocortisone in diseases of cortisol deficiency. There is a high unmet need for adult patients suffering from AI across Europe with current treatment options leading to poor quality of life. We believe modified-release hydrocortisone has the potential to replicate the physiological overnight rise of cortisol in these patients and we look forward to the data readout from the CHAMPAIN study in H2 2022."

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).

Notes to Editors

About adrenal insufficiency

Adrenal insufficiency (AI) is an orphan condition caused either by failure of the adrenal gland to produce cortisol (primary AI) or can result from many factors that lead to suppression of the hypothalamic- pituitary axis (secondary AI). The result is a decrease / absence of cortisol production resulting in a number of comorbidities for patients such as lack of energy, weakness and a low mood.

AI may also lead to adrenal crisis, particularly during times of increased cortisol requirements (e.g. surgery, infection, or trauma) as patients are unable to mount a stress response. Life-threatening symptoms such as severe dehydration, hypotension, hypovolaemic shock, altered consciousness, seizures, stroke, or cardiac arrest may develop; if left untreated, adrenal crisis may lead to death or permanent disability. The condition is estimated to affect 298,000 patients in Europe and the UK.

Current therapy in Europe and the UK for AI either uses generic hydrocortisone or Plenadren® (modified-release hydrocortisone tablets). However, these preparations are unable to replicate the physiological overnight rise of cortisol in AI patients leading to fatigue and poor quality of life, especially in the morning.

About DNL-0200 (modified-release hydrocortisone hard capsules)

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 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®) 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® 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® 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: February 2022 Code: CORP-EU-0026