UK-based specialty pharma company Diurnal Group said that its adrenal drug Chronocort failed to meet the primary objective of a phase 3 trial in adults with congenital adrenal hyperplasia (CAH).
Chronocort was not successful in confirming its superiority over conventional treatment in endocrine control over a 24-hour period during the late-stage clinical trial held in Europe.
Diurnal Group said that its adrenal drug could achieve control on a lower overall dose of glucocorticoid with fewer patients needing rescue therapy.
However, the modified release formulation of its investigational adrenal drug designed to give overnight cortisol release, removed the early morning peak in androgen levels which were otherwise seen using conventional therapy.
The phase 3 trial held across seven countries and 11 clinical trial sites featured 122 patients with congenital adrenal hyperplasia. Patients being treated for the condition with combinations of standard-of-care generic steroids were enrolled in the late-stage trial and randomized to either Chronocort on a twice-daily regime or were continuing their standard of care regimen.
The UK-based specialty pharmaceutical company said that it will discuss the implications of the overall trial findings, including interim data from the currently held long-term dosing study, with the regulatory authorities.
In its phase 2 trial though, Chronocort met its primary endpoint by fully characterizing its pharmacokinetic profile in 16 male and female adult subjects with CAH.
Diurnal CEO Martin Whitaker said: “We are surprised by these results, following our previously successful Phase II clinical trial in CAH. 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.
“We 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 Chronocort development, and discuss these with the regulatory authorities.”
Chronocort is a modified release preparation of hydrocortisone. The adrenal drug has been designed to mimic the circadian rhythm of cortisol to regulate excess levels of androgen and chronic fatigue in patients with diseases of cortisol deficiency.