IP Group PLC Portfolio co Diurnal headline data for Chronocort
October 08 2018 - 1:07AM
RNS Non-Regulatory
TIDMIPO
IP Group PLC
08 October 2018
FOR RELEASE ON 08 October 2018
IP Group plc - Portfolio company Diurnal announces headline data
for Chronocort(R) 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(R) pivotal Phase
III clinical trial in Europe for adults with congenital adrenal
hyperplasia (CAH). Both regimens used in the trial - regular
adjustment of Chronocort(R) 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(R) to
conventional therapy in endocrine control over the 24-hour period:
as titration of conventional therapy achieved control as good as
titration of Chronocort(R) , 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(R) achieved control on a lower overall dose of
glucocorticoid with fewer patients requiring rescue therapy (sick
day rules). The modified release formulation of Chronocort(R) ,
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(R) 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
+44 (0) 20 7444 0050
Alan Aubrey, Chief Executive Officer
Greg Smith, Chief Financial Officer +44 (0) 20 7444 0062/+44 (0)
Liz Vaughan-Adams, Communications 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
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END
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