LONDON (Alliance News) - Diurnal Group PLC said Monday its phase-three European trial of Chronocort did not meet its primary objective, causing shares in the pharmaceutical company to plummet.
Intellectual property business developer IP Group PLC, which holds a 44% stake in Diurnal, made a separate announcement noting the result.
Diurnal shares fell 54% to 49.20p in trading on AIM in London early Monday, while shares in FTSE 250-constituent IP Group were down 3.8% at 121.20 pence.
Chronocort is intended to treat congenital adrenal hyperplasia, an orphan condition in which patients have a block in cortisol production. This lack of cortisol causes the over-production of male hormones, and can lead to infertility and increased mortality.
The goal of the phase three trial was to "demonstrate the superiority of Chronocort to conventional therapy", a goal which was not met as both Chronocort and conventional therapy proved equivalent.
"The implications of the overall trial results, including interim data from the ongoing long-term dosing study, will be discussed with the regulatory authorities," said IP Group.
Diurnal said that while the primary objective was not met, the trial did show that Chronocort achieved control on a lower overall dose with fewer patients requiring rescue therapy.
Dirunal also noted that the modified release formulation of Chronocort eliminated the peak in male hormones in the early morning, unlike conventional treatment.
"We are surprised by these results, following our previously successful phase two clinical trial," said Dirunal Chief Executive Martin Whitaker.
"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," Whitaker added.
The company said it will update the market "in due course" as to whether these results will impact its development of Chronocort in the US, where a phase three trial has just begun.
