Diurnal Group, a United Kingdom-based specialty pharmaceutical company, has completed patient enrolment in its European pivotal Phase III clinical trial of Chronocort (modified release hydrocortisone), it was reported yesterday.

The product is intended for the treatment of congenital adrenal hyperplasia in adults. The Phase III trial is an open label study in which adult patients with congenital adrenal hyperplasia, presently treated with a single or combination of generic steroids (standard-of-care), are randomised to either receive Chronocort on a twice daily 'toothbrush' regimen or continue on their standard-of-care regimen. The primary endpoint of the trial will be the control of androgens at six months on equivalent or lower total daily dose of steroid when treated with Chronocort compared to standard-of-care treatment.

This primary endpoint is similar to an endpoint previously reported in the Phase II clinical trial, where the data showed a significant reduction in the morning levels of 17-hydroxyprogesterone (the main androgen) in patients after six months on Chronocort (median 70nmol/l vs 5.65nmol/l p= 0.014), with 94% of values in the normal or optimal range compared to 31% before Chronocort therapy. Secondary endpoints will include an assessment of fatigue levels and the relative effect of Chronocort on body mass index and bone turnover, all of which are indicative of clinical benefits. Headline data from this trial is expected in the third quarter of 2018 and, if positive, could lead to potential market authorisation in Europe in 2020.

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.