IP Group cheers progress with Diurnal's Chronocort treatment
Intellectual property-based business investor and developer IP Group reported on Thursday that its portfolio company Diurnal Group had received formal scientific advice from the European Medicines Agency confirming the current clinical and regulatory path for ‘Chronocort’ as a treatment for adults with congenital adrenal hyperplasia (CAH).
The FTSE 250 firm said that as a result, Diurnal intended to submit a marketing authorisation application for Chronocort - modified release hydrocortisone - in the fourth quarter of 2019 based upon the existing clinical data, including data to support orphan drug status in the treatment of CAH.
It said that positive outcome followed the submission of a regulatory package requesting scientific advice to the EMA for Chronocort, based on detailed analysis of data from its phase 3 study - the largest ever clinical trial programme in CAH - and the open-label safety extension study.
IP Group said it currently held a direct undiluted beneficial stake of 43.3% in Diurnal, which it described as a specialty pharmaceutical company targeting patient needs in chronic endocrine, or hormonal, diseases.
“This positive development means that the EMA has not requested a further clinical study of Chronocort, despite the recent phase 3 not meeting its primary endpoint, and is consistent with Diurnal's intention to file its marketing application this year based on the existing data,” said Dr Sam Williams, IP Group’s managing partner in the life sciences sector.
“This supports IP Group's view that the chances of approval of Chronocort in Europe are very good and, moreover, that there remains the potential for orphan status, which would give Chronocort significant advantages over existing treatments for CAH.”
IP Group said CAH was an orphan condition caused by a block in cortisol production - an essential adrenal steroid hormone required for healthy life.
A lack of cortisol in turn caused the overproduction of male steroid hormones, or androgens.
Cortisol deficiency and overproduction of androgens could lead to increased mortality, infertility and severe development defects, including ambiguous genitalia, precocious puberty and short stature.
Sufferers, even if treated, remained at risk of death through an adrenal crisis.
The condition was estimated to affect a total of around 47,000 patients in Europe, and more than 400,000 in the rest of the world.