Enrollment complete in Ph II/III DuoCort trial

Helsingborg, Sweden-based DuoCort Pharma AB says that targeted enrollment is complete in a pivotal Phase II/III trial evaluating 5mg and 20mg DuoCorts 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 subjects. Given the small 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 the European Medicines Agency (EMEA) 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 European Union in May 2006. Interim data from the study is expected to be available in third-quarter 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 three times-daily oral hydrocortisone therapy in patients with primary adrenal insufficiency. The trial commenced in August 2007 and is being conducted at five University endocrinology clinics, the firm noted.