Diurnal kicks off adrenal condition trial with first patients

Specialist pharmaceutical company Diurnal said it had enrolled the first two patients in its US-based Chronocort phase III trial for adults with congenital adrenal hyperplasia (CAH).

The trial, which will eventually recruit as many as 150 patients, is designed to study treatment interventions in adults with CAH in the US and is expected to be completed in late 2020, with an NDA filing planned for 2021.

The patients will either receive Chronocort twice-daily or their current standard of care.

CAH is caused by a drop in production of cortisol, a steroid hormone that is essential for a healthy life, and causes over production of male steroid hormones, resulting in increased mortality, infertility and development defects such as ambiguous genitalia, precocious puberty and short stature.

Martin Whitaker, chief executive of Diurnal, said: "The majority of patients with this condition are not being adequately treated with current therapy, leading to poor disease control. We believe Chronocort is able to address this unmet need by providing a drug release profile in line with the body's natural cortisol circadian rhythm."

Treatment of CAH in the US has an estimated market size of $110m, with an estimated $880m market for the closely related adrenal insufficiency condition.

"The US represents an important opportunity for Chronocort to improve the lives of patients with diseases of cortisol deficiency whose needs are currently not being met by treatments available," said Whitaker

Diurnal’s shares were down 2.25% at 108.50p at 0936 BST.