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DuoCort Pharma AB has announced that targeted enrolment is now complete in the pivotal phase II-III clinical trial evaluating 5mg and 20mg DuoCort dual-release hydrocortisone tablets for the treatment of adrenal insufficiency – the inability of the body to produce sufficient amounts of the essential hormone cortisol.
With a target of 56 patients, the five sites participating in the trial have now enrolled 59 patients.
Given the small patient numbers in this rare disease, inclusion of identified patients is continuing and will close at the end of the year.
The trial protocol was reviewed by EMEA in a protocol assistance procedure under the orphan drug programme and accepted as a pivotal study.
DuoCort was designated as an orphan drug in the EU in May 2006.
Interim data from the study are expected to be available later next year.
The pivotal phase II-III trial is a controlled study assessing the pharmacokinetics, safety and tolerability of once-daily DuoCort in comparison to conventional thrice-daily oral hydrocortisone therapy in patients with primary adrenal insufficiency (Addison’s disease).
The trial commenced in August 2007 and is being conducted at five university endocrinology clinics.
The patients who have so far completed the run-in phase and who have been randomised to DuoCort are all reported to be doing well.
The primary aim is to compare bioavailability between once-daily DuoCort dual-release hydrocortisone tablets and conventional hydrocortisone replacement therapy.
Secondary aims include comparing short- and long-term safety, tolerability and efficacy of DuoCort to conventional replacement therapy and assessing the safety of using DuoCort as “rescue therapy” during minor intercurrent illnesses.
Interim analysis is planned six months after inclusion of the last patient, with data expected to be available in the third quarter of 2008.
Dr Gudmundur Johannsson, Chief Medical Officer of DuoCort, said this phase II-III trial was key to demonstrating the significant benefit of once-daily cortisol replacement which effectively mimicked the physiological diurnal release profile of cortisol.
“We are encouraged by the rapid enrolment into this trial, given the small patient population and we acknowledge all of our investigators for their commitment to this trial,” said Dr Johannsson.
“Current research confirms that conventional therapy is suboptimal and is not serving these patients as well as it should.
“There is scope for improvement in the delivery of cortisol replacement and we are convinced DuoCort will deliver better long-term outcomes.
“This trial is a major step toward offering a better treatment option for patients with adrenal insufficiency.”