HELSINGBORG, Sweden, December 11, 2007 / b3c newswire / - DuoCort Pharma AB announced today 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.
Dr. Gudmundur Johannsson, Chief Medical Officer of DuoCort, said this Phase II-III trial is key to demonstrating the significant benefit of once-daily cortisol replacement which effectively mimics 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 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.”
About adrenal insufficiency
Recent research on adrenal insufficiency patients taking currently available glucocorticoid replacement therapy demonstrates reduced bone density, unfavourable cardiovascular risk profiles and compromised quality of life and well-being. Recent data also suggest an almost 3-fold increased mortality. Improvement in the replacement regimen and replacement strategy is therefore essential. Chronic adrenal insufficiency is a rare disease that affects at least 125,000 patients in the European Union.
About DuoCort™ dual-release hydrocortisone
DuoCort™ dual-release 5 mg and 20 mg hydrocortisone tablets for patients with chronic adrenal insufficiency were granted an Orphan Medicinal Product Designation in the European Union in May 2006. DuoCort’s objective is to improve today’s glucocorticoid replacement therapy with a tablet that delivers a more physiological profile of hydrocortisone, better mimicking the body’s natural cortisol release by combining rapid release and extended release characteristics. DuoCort™ is a once-daily tablet which is more convenient than current treatment and capable of improving patient compliance.
About DuoCort Pharma
DuoCort Pharma AB is a drug development company focussed on improving glucocorticoid therapy in areas of significant unmet medical need. For more information about DuoCort and its drug development programs, contact Greg Batcheller, CEO, tel. +46 46 288 5008. www.duocort.com