Diurnal Group has decided to put a hold on all activities relating to the US development of its adrenal drug Chronocort following a failure in a recently concluded phase 3 trial in adults with congenital adrenal hyperplasia (CAH).
Earlier this month, the company said that Chronocort could not confirm its superiority over conventional treatment in endocrine control over a 24-hour period, which was the primary objective of the late-stage clinical trial held in Europe.
The UK-based specialty pharmaceutical company said that it had carried out further analysis of the clinical trial data from the phase 3 trial to identify key differences between Chronocort and the control arm of the trial.
It also analyzed interim data from an ongoing safety extension study in Europe, an open-label, ‘roll-over’ trial in which patients from the phase 3 trial have continued treatment with the investigational adrenal drug.
The company said that several patients on the safety extension trial have been treated for more than 12 months and have shown sustained benefit from extended Chronocort treatment. This was on par with feedback from the study investigators in the open-label trial, said Diurnal.
The company said that depending on more analyses of data from the trials, it plans to seek a Scientific Advice meeting with European regulators by the year end for the submission of a marketing authorization application (MAA) for Chronocort in the fourth quarter of 2019.
Included in this would be an application for orphan drug designation for the treatment of congenital adrenal hyperplasia.
Diurnal CEO Martin Whitaker said: “We remain positive that Chronocort will provide a valuable treatment option for patients with CAH and look forward to discussing our extensive data set with regulators.
“In light of our observations regarding the European Phase III trial data, and the requirement to manage our costs carefully, we have taken the decision to put all Chronocort US development activity on hold, and to adjust our cost base accordingly.”
Separately, Diurnal said that it has wrapped up a development program for a US New Drug Application (NDA) submission for Alkindi, including a study to show its bioequivalence with the US reference product.