With a target of 56 patients, the five sites participating in the trial have now enrolled 59 patients. The company said that given the small patient numbers in this rare disease, inclusion of identified patients is continuing and will close by the end of 2007.
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 protocol was reviewed by the European Medicines Agency in a protocol assistance procedure under the orphan drug program and accepted as a pivotal study.
Gudmundur Johannsson, chief medical officer of DuoCort, said: “We are encouraged by the rapid enrollment into this trial, given the small patient population, and we acknowledge all of our investigators for their commitment to this trial. 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.”