Diurnal Group (LON:DNL) is the topic of conversation when Hardman & Co Analyst Dr Martin Hall joins DirectorsTalk to discusses the recent Phase lll Chronocort trial. Martin explains how it differs from the Phase ll trial, what affect it has on the overall commercial program and his thoughts on the share price.
Diurnal Group plc, the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, provided an update on its late-stage pipeline products for the replacement of cortisol deficiency, Alkindi® (hydrocortisone granules in capsules for opening) and Chronocort® (modified release hydrocortisone).
Following the Company’s announcement on 8 October 2018 that Chronocort® had not met the primary endpoint in its European Phase III trial for the treatment of congenital adrenal hyperplasia (CAH), Diurnal has undertaken further analysis of the clinical trial data, identifying important differences between Chronocort® and the control arm of the trial. Diurnal has also analysed interim data from the ongoing safety extension study in Europe, an open-label, ‘roll-over’ trial in which patients from the Phase III trial have continued Chronocort® treatment. Notably, a number of patients on the safety extension trial have now been treated for at least 12 months and show sustained benefit from extended Chronocort® treatment, consistent with feedback from the study investigators in this open-label trial. Based on the further analyses of data from these largest ever treatment studies in CAH, Diurnal intends to request a Scientific Advice meeting with European regulators before the end of the 2018, with a view to submitting a Marketing Authorisation Application (MAA) for Chronocort® in Q4 2019, including application for Orphan Drug Designation in the treatment of CAH.
While the comprehensive dataset from the European trials is analysed, and until the implications for CAH care are understood, Diurnal has put on hold all activities relating to the US development of Chronocort®.
Separately, for Alkindi®, Diurnal has now completed a development programme for a US New Drug Application (NDA) submission, including a study to demonstrate bioequivalence with the US reference product. The Company will now proceed to an end-of-Phase III meeting with the US Food and Drug Administration (FDA) at the earliest opportunity to seek agreement that the package of data is suitable for an NDA submission, planned for Q3 2019.
Martin Whitaker, Chief Executive Officer of Diurnal, commented:
“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.
We continue to be pleased with the progress of the commercial roll-out of our lead product, Alkindi®, across Europe following its launch in May 2018. We expect by early 2019 that Alkindi® will be commercially available in the UK, Germany, Austria and the Nordic region. We also remain focused on completing pricing negotiations in key European territories as well as the finalisation of the clinical data package for Alkindi® in the US for submission to the FDA.”