Successful phase II/III trial of new therapy for adrenal insufficiency

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Friday, 12 June 2009 12:01 (UTC + 2)

 

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Embargoed story- This story cannot be used until June 12th 1.30 pm EDT (=GMT- 4)

Helsingborg Sweden/ Washington DC June 12th 2009 /
b3c newswire /- 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. 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 therapyis 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.

The ENDO 2009 abstract of our Phase II/III data is available online at:
http://www.abstracts2view.com/endo/view.php?nu=ENDO09L_P3-614


About adrenal insufficiency
Patients suffering from adrenal insufficiency (cortisol deficiency) are unable to produce their own cortisol and need replacement therapy to survive. Adrenal insufficiency is a rare disease that affects patients in their active years and, because it is a chronic condition, they require this life-saving therapy throughout their lives. Treatment of adrenal insufficiency involves replacing, or substituting, the hormones that the adrenal glands are not making. Cortisol is replaced using hydrocortisone, the synthetic form of cortisol, and sometimes with other corticosteroids.



About chronotherapy
Coordinating biological rhythms (chronobiology) with medical treatment is called chronotherapy. It takes into account the body's biological rhythms in determining the timing--and sometimes the amount--of medication to optimize a drug's desired effects and minimize its undesired ones.
Chronotherapy for the most part is not about new drug substances but about using medicines in new ways, better attuned to the body’s needs. Designing a drug so its release into the bloodstream has a particular release pattern or using pumps that deliver medicine at specified intervals are some of the innovations that may reap important benefits.



About DuoCort
DuoCort is a drug development company focused on improving glucocorticoid therapy in several areas of medical need. The company has its origins among researchers at the Sahlgrenska University Hospital in Gothenburg and at Uppsala University in Sweden. DuoCort is developing an improved glucocorticoid replacement therapy for patients with adrenal insufficiency, a rare disease for which DuoCort has orphan drug designations in Europe and the USA. The new product, a once daily dual-release hydrocortisone oral tablet that comes in both 5 mg and 20 mg sizes, is being developed by DuoCort Pharma AB, a wholly-owned subsidiary. For more information on DuoCort please visit www.duocort.com.


Contact information
Medical spokesperson: Gudmundur Johannsson Tel +46 705 280 872
Corporate spokesperson: Maria Forss Tel +46 709 670 007