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Portfolio co Diurnal headline data for Chronocort

8 Oct 2018 07:07

RNS Number : 2427D
IP Group PLC
08 October 2018
 

FOR RELEASE ON

08 October 2018

 

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.

 

For more information, please contact:

 

IP Group plc

www.ipgroupplc.com

Alan Aubrey, Chief Executive OfficerGreg Smith, Chief Financial OfficerLiz Vaughan-Adams, Communications

+44 (0) 20 7444 0050+44 (0) 20 7444 0062/+44 (0) 7979 853802

Charlotte Street Partners

Andrew Wilson

+44 (0) 7810 636995

Martha Walsh

+44 (0) 7876 245962

 

Notes for editors

 

About IP Group

 

IP Group is a leading intellectual property commercialisation company which focuses on evolving great ideas, mainly from its partner universities, into world-changing businesses. The Group has pioneered a unique approach to developing these ideas and the resulting businesses by providing access to business building expertise, capital (through its 100%-owned FCA-authorised subsidiaries IP Capital and Parkwalk Advisors), networks, recruitment and business support. IP Group has a strong track record of success and its portfolio comprises holdings in early-stage to mature businesses across life sciences and technology. IP Group is listed on the Main Market of the London Stock Exchange under the code IPO.

Group holdings in portfolio companies reflect the undiluted beneficial equity interest excluding debt, unless otherwise explicitly stated.

For more information, please visit our website at www.ipgroupplc.com.

 

ENDS

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
 
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