Diurnal Group completes phase III Chronocort clinical patient enrolment
Source - SMW
Diurnal Group said that it completed patient enrolment for its European pivotal Phase III clinical trial of Chronocort for the treatment of Congenital Adrenal Hyperplasia (CAH) in adults.
The Phase III trial is an open label study in which adult patients with CAH, currently treated with a single or combination of generic steroids.
Chronocort has been granted Orphan Drug Designations in Europe and the US in the treatment of CAH, which, if confirmed at marketing authorisation, provides market exclusivity for 10 years in Europe and seven years in the US post market authorisation.
Martin Whitaker, Chief Executive Officer of Diurnal, 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. We look forward to reporting headline data from this trial in 2018.'