DuoCort completes enrolment for pivotal phase II-III adrenal insufficiency trial
DuoCort Pharma AB announced that targeted enrolment is complete in the pivotal phase II-III clinical trial evaluating 5 mg and 20 mg 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 year-end. The trial protocol was reviewed by EMEA, the European Medicines Agency, in a Protocol Assistance procedure under the Orphan Drug program and accepted as a pivotal study. DuoCort was designated as an Orphan Drug in the EU in May 2006. Interim data from the study is expected to be available in Q3 2008.
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 randomized 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 Q3 2008.
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