Portfolio co Diurnal headline data for Chronocort

IP Group plc - Portfolio company Diurnal announces headline data for Chronocort^® European Phase III clinical trial

IP Group plc (LSE: IPO) ("IP Group" or "the Group"), the developer of intellectual property-based businesses, notes that its portfolio company Diurnal Group plc ("Diurnal" or "the Company"), has announced headline data from the Chronocort^® pivotal Phase III clinical trial in Europe for adults with congenital adrenal hyperplasia (CAH). Both regimens used in the trial - regular adjustment of Chronocort^® and conventional glucocorticoid doses according to endocrine response and symptoms (with the adjustments being mandated by a blinded physician) - controlled androgens (sex hormones) over a 24-hour period. The stated primary objective of the protocol was to demonstrate superiority of Chronocort^® to conventional therapy in endocrine control over the 24-hour period: as titration of conventional therapy achieved control as good as titration of Chronocort^®, the primary objective of the trial was not met.

IP Group currently holds a direct undiluted beneficial stake of 43.6% in Diurnal, a specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases.

Chronocort^® achieved control on a lower overall dose of glucocorticoid with fewer patients requiring rescue therapy (sick day rules). The modified release formulation of Chronocort^®, designed to provide overnight cortisol release, eliminated the early morning peak in androgen levels seen using conventional therapy. 

The implications of the overall trial results, including interim data from the ongoing long-term dosing study, will be discussed with the regulatory authorities.

The Phase III trial was designed in agreement with the European Medicines Agency (EMA) and conducted in a total of 122 patients with CAH across seven countries and 11 clinical trial sites. Patients being treated for CAH with combinations of generic steroids (standard-of-care) were enrolled on the trial and randomised to either Chronocort^® on a twice-daily regime or continued their standard of care regimen.

CAH is 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 causes the over-production of male steroid hormones (androgens). Cortisol deficiency and over-production of androgens can lead to increased mortality, infertility and severe development defects, including ambiguous genitalia, precocious puberty and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. The condition is estimated to affect a total of approximately 47,000 patients in Europe, with over 400,000 in the rest of the world.

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