UK-based Diurnal Group (AIM: DNL) has announced that the Journal of Clinical Endocrinology and Metabolism (JCEM) has published the Phase III trial and extension study for Chronocort (hydrocortisone modified-release hard capsules) in congenital adrenal hyperplasia (CAH).
Diurnal’s Phase III study was conducted in a total of 122 patients enrolled across 11 clinical sites, the largest ever interventional trial completed in CAH patients. Data are also presented from an open-label safety extension study for patients completing treatment in the Phase III trial.
"This data has also formed part of our submissions to the EMA and MHRA"These data assessed the impact of treatment with Chronocort over a further period of 18 months. A significant proportion of patients eligible to enter the follow-on study did so, and patient retention rates in the study remain high.
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