LONDON (Alliance News) - Pharmaceutical company Diurnal Group PLC on Friday said the first two patients have been enrolled into its phase three US trial of Chronocort.
Chronocort is a modified release form of hydrocortisone, and is intended to treat congenital adrenal hyperplasia, or CAH. It was granted orphan drug states in the US, and could be granted market exclusivity for seven years if authorised.
CAH is a condition in which patients have a block in cortisol production. This lack of cortisol causes the over-production of male hormones, and can lead to infertility and increased mortality.
Diurnal said the US is the core market for Chronocort, having an estimated market size of GBP110 million for the treatment of CAH.
A related condition, adrenal insufficiency, has an even larger market of USD880 million, and Dirunal intends to commence a phase two trial of Chronocort in patients with this disease at the end of 2018. The orphan drug status of Chronocort also applies to patients with adrenal insufficiency.
"We are pleased to have enrolled the first patients in this pivotal study for congenital adrenal hyperplasia. The majority of patients with this condition are not being adequately treated with current therapy, leading to poor disease control," said Diurnal Chief Executive Martin Whitaker.
"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," Whitaker added.
Shares in Diurnal were untraded at 108.50 pence on Friday.