Diurnal's endocrine drug does not meet trial objective

(Sharecast News) - Clinical trials of Diurnal Group's Chronocort drug failed to meet the primary objective of proving superior to conventional therapy in endocrine control over a 24-hour period.Tested on 122 adults across seven countries with congenital adrenal hyperplasia who had been treated with combinations of generic steroids were randomised to either Chronocort on a twice-daily regime or continued their standard of care regimen.Chronocort achieved control on a lower overall dose of glucocorticoid with fewer patients requiring rescue therapy.A modified release formulation of Chronocort, designed to provide overnight cortisol release, eliminated the early morning peak in androgen levels seen using conventional therapy."We are surprised by these results," said Diurnal chief executive Martin Whitaker, following the previously successful Phase II clinical trial in congenital adrenal hyperplasia."However, these initial results confirm the concept of Chronocort, that early morning control of androgens can be achieved with a modified release preparation of hydrocortisone."Diurnal will now analyse the full data set from this trial, along with interim data from the ongoing Chronocort long-term dosing study, to determine next steps in the drug's development and discuss these with the regulatory authorities."We remain confident that Chronocort will be a valuable treatment option for CAH patients," Whitaker said.Diurnal, in which IP Group is a major shareholder, recently bagan a Phase III study in congenital adrenal hyperplasia in the USA, focussed particularly on morning control of androgens.