StockMarketWire.com - Pharmaceutical group Diurnal said Friday the first two patients had been enrolled into its phase III clinical trial in the US for adults with congenital adrenal hyperplasia.

The phase III clinical trial was designed to study treatment interventions in adults in the US with congenital adrenal hyperplasia, a group of genetic conditions that affect the adrenal glands.

It was expected to be completed in late 2020, with an NDA filing in the US planned for 2021, the company said.

The primary objective of the study, 'Restore,' would be to assess the proportion of patients achieving biochemical control with the company's treatment, Chronocort, or standard of care.

The study would also assess the impact of treatment on a number of important clinical outcomes, the company said.

Up to 150 patients would participate in the 52 weeks study. The patients were expected to be randomised to either receive Chronocort twice-daily or their current standard of care.

'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 Martin Whitaker, Chief Executive Officer of Diurnal.

'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. 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.'

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