DuoCort gained promising data from its phase-II/III study for the rare and life threatening disease adrenal insufficiency. DuoCort's new form of physiological treatment with once-a-day hydrocortisone dosing show improved cardiovascular and metabolic measures compared to standard hydrocortisone tablets given thrice daily. The company presented the data at the 91st annual ENDO congress in Washington.
DuoCort's new drug has been developed to have a physiological release profile that mimics the body's natural secretion pattern of cortisol to improve outcomes for patients. Results from the phase-II/III study in 64 patients show a physiological diurnal serum cortisol profile that resulted in significantly improved cardiovascular and metabolic profiles, with reduced body weight and blood pressure. Glucose metabolism improved, in particular in patients with diabetes mellitus. The new DuoCort therapy was safe, well accepted and well tolerated.
Endocrinology professor and chief medical officer at DuoCort, Gudmundur Johannsson says, "This new more physiological chronotherapy has excellent potential to significantly improve cortisol replacement in all types of adrenal insufficiency. The positive cardiovascular and metabolic effects and once daily therapy will make this a welcome new treatment option to help patients lead a more normal life."
Adrenal insufficiency in its untreated state is a highly deadly condition. Current therapy is long outmoded, with no major drug improvements since at least the 1960s.
Increasing interest in adrenal insufficiency during the past 10 years has resulted in studies showing premature death, compromised quality of life, increased cardiovascular risk and reduced bone mineral density among patients with adrenal insufficiency. The likely cause is the highly un-physiological glucocorticoid replacement delivered by even the best therapy available today. The large unmet medical need is to improve therapy by mimicking the sizable diurnal variation in serum cortisol that normally occurs. DuoCort seeks to do so by providing a so-called chronotherapy with a once-a-day dosing to further enhance the physiological profile.