Cardiff, UK – Diurnal Limited is pleased to announce an extension to its existing Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH), Maryland, US. The term of this CRADA will be extended until June 2021.
The extension will support a Phase III clinical study of Diurnal’s product Chronocort® - a modified release formulation of hydrocortisone - for the treatment of the orphan disease Congenital Adrenal Hyperplasia.
Diurnal has already collaborated successfully with the NIH to complete a Phase II study of Chronocort® which met its primary objective of fully characterising the pharmacokinetic profile of Chronocort® in adult subjects with Congenital Adrenal Hyperplasia. The results show Chronocort® provides circadian levels of the stress hormone cortisol similar to the healthy population mimicking the overnight rise in cortisol levels, such that, patients wake with a normal cortisol level.
In addition, the secondary objective of examining the effect of Chronocort® on the biochemical efficacy markers of the disease showed significant control of the 24-hr levels of the androgens, 17-hydroxyprogesterone (170HP) and androstenedione (A4) which were brought into their optimal ranges after 6 months treatment with titrated Chronocort® compared to standard treatment.
Martin Whitaker, Chief Executive Officer, Diurnal, stated:
"We are delighted that Diurnal has extended its CRADA with the National Institutes of Health and we look forward to continuing our work with the NIH clinical team to assess the effectiveness of Chronocort® in Congenital Adrenal Hyperplasia patients"
Please direct all enquiries to:
Martin Whitaker, CEO
+44 (0)871 716 8848