Successful phase II/III trial of new therapy.
- Details
- Published on Friday, 12 June 2009 01:00
Helsingborg Sweden/Washington DC June 12th 2009 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 presents the data
at the 91st annual ENDO congress in Washington DC.
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.
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