The Phase I study showed that both the DuoCort 5 mg and 20 mg hydrocortisone dual-release tablets were safe and well tolerated. The novel dual-release formulation showed a rapid increase in cortisol levels after single-dose administration, the dose was well absorbed and it had similar bioavailability to the oral hydrocortisone in the literature. Moreover, the data showed no risk of dose accumulation. The release profile closely resembled the physiological one, including the natural nocturnal cortisol free interval.
Based on the promising Phase I data, DuoCort is now launching its Phase II / III program. "We are very pleased with the outcome of the Phase I trial, especially as there was very little inter- or intra-individual variability in the pharmacokinetics and the drug release profiles look very like the physiological release profile of cortisol in healthy individuals," said DuoCort's Chief Medical Officer, Dr Gudmundur Johannsson. "The Phase II trial will seek to demonstrate similar safety, tolerability and pharmacokinetics in patients, as well as gathering other safety and quality of life data."
About dual-release hydrocortisone
DuoCort's 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 once-daily tablet which is more convenient than current treatment and capable of improving pat ient compliance. In addition, by combining rapid release and extended release characteristics, DuoCort's new tablet also delivers a more physiological dose of hydrocortisone, better mimicking the body's natural cortisol serum profile.
About adrenal insufficiency
Recent research on adrenal insufficiency patients taking currently available glucocorticoid replacement therapy demonstrates reduced bone density and unfavourable cardiovascular risk profiles. Recent data also suggest an almost 3-fold increased mortality. Chronic adrenal insufficiency is a rare disease that affects at least 125,000 patients in the European Union.
About DuoCort AB
DuoCort is a drug development company focussed on improving glucocorticoid therapy in several areas of medical need. DuoCort was founded in 2003 by PULS, an early-stage life sciences investment and business development group (www.pulsinvest.se). www.duocort.com
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Greg Batcheller, CEO, +46 73 391 9608