DuoCort: New Chronotherapy for Adrenal Insufficiency
News Jul 09, 2009
DuoCort publishes data from its Phase I study for the rare and life threatening disease adrenal insufficiency. The release profile of DuoCort’s new form of treatment with once-a-day hydrocortisone dosing closely resembles the physiological secretion pattern. The data is published in the European Journal of Endocrinology.
DuoCort’s new drug has been developed to produce a physiological release profile that mimics the body´s natural secretion pattern of cortisol to improve outcomes for patients.
Results from the phase I study in healthy volunteers, evaluating the safety and pharmacokinetics of the new hydrocortisone tablet, show a physiological diurnal serum cortisol profile after single-dose administration that mimics the natural secretion pattern of cortisol.
The new DuoCort therapy showed no absorption failure allowing it to be safely used in patients with adrenal insufficiency. Data from a subsequent phase II/III trial in patients with primary adrenal insufficiency or Addison’s disease, presented at a scientific congress in June confirmed the findings in the phase I study and showed the new therapy to be well tolerated and safe.
Endocrinology Professor and Chief Medical Officer of DuoCort, Gudmundur Johannsson says, “We are very pleased with the outcome of the Phase I trial, especially as there was 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. This new more physiological chronotherapy has excellent potential to significantly improve cortisol replacement in all types of adrenal insufficiency”
The Alzheimer drug candidate PRI-002 has successfully completed Phase I of clinical research involving healthy volunteers. When administered daily over a period of four weeks, the active substance proved to be safe for use in humans. The next milestone will be the proof of efficacy in patients in clinical Phase II.READ MORE