UK-based specialty pharma company Diurnal Group has completed enrolling patients in its pivotal Phase III clinical trial of Chronocort (modified release hydrocortisone) for the treatment of congenital adrenal hyperplasia (CAH) in adults.
As part of the open-label trial, CAH patients currently treated with a single or combination of generic steroids have been randomised to either receive Chronocort on a twice-daily ‘toothbrush’ dosage or continue on their standard-of-care regimen.
The trial’s primary objective is the control of androgens at six months on equivalent or reduce the total daily dose of steroid when treated with Chronocort compared to standard-of-care treatment.
Secondary endpoints comprise an evaluation of fatigue levels and the relative effect of Chronocort on body mass index and bone turnover.
Headline data from the trial is scheduled to be available by the third quarter of this year. Chronocort is expected to receive market authorisation in Europe in 2020, subject to the successful completion of the trial.
Diurnal Group CEO Martin Whitaker said: “Chronocort provides a drug release profile that has been designed to mimic the body’s natural cortisol circadian rhythm more closely and therefore has the potential to achieve better CAH disease control for patients than current treatment options.
“As the majority of CAH patients have poor disease control, we believe Chronocort offers the potential to significantly improve many of the symptoms of this debilitating condition.”
CAH is an orphan condition usually caused by a deficiency of the enzyme 21-hydroxylase, which is required to generate the adrenal steroid hormone, cortisol.
The condition is reported to be inherited and affects both sexes.