First adrenal insufficiency patient dosed in Phase 2 study

Diurnal has announced that the first patient has been dosed in its phase 2 European clinical trial of modified-release hydrocortisone.

It is treating people with adrenal insufficiency (AI), also known as Addison’s disease, while the trial also represents a significant marketing opportunity for the company across Europe and throughout the UK.

The CHAMPAIN phase 2 study aims to evaluate the efficacy, safety and tolerability of modified-release hydrocortisone versus Plenadren in AI. It is anticipated that it will take six months to reach completion.

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 for congenital adrenal hyperplasia (CAH). It is approved for the latter disease in Europe and the UK under the commercial name Efmody.

AI is a long-term endocrine disorder, which affects approximately 298,000 patients in Europe and the UK. It is 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 may be life-threatening.

Martin Whitaker, CEO 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,” he added.