Diurnal Group PLC First Patient Dosed in Testosterone Trial (6142P)
21 November 2016 - 6:00PM
UK Regulatory
TIDMDNL
RNS Number : 6142P
Diurnal Group PLC
21 November 2016
21 November 2016
Diurnal Group plc
("Diurnal" or the "Company")
First patient dosed in testosterone replacement therapy for
hypogonadism
Potential to be the first effective oral native testosterone
treatment
Data expected in mid-2017
Represents third product into clinical development, another
significant step towards building a proprietary endocrinology
franchise
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that it has successfully dosed the first
patient in the Company's native oral testosterone formulation
(DITEST) Phase I clinical trial. This study will evaluate
pharmacokinetics, safety and tolerability of DITEST in the target
patient group of males with hypogonadism (Clinical Trials ID
NCT02966652).
Dr Martin Whitaker, CEO of Diurnal, commented:
"The start of this trial is another meaningful step towards
achieving Diurnal's vision of becoming one of the world's leading
endocrinology speciality pharma companies. DITEST is our next
pipeline product to enter clinical development after Infacort(R)
and Chronocort(R) , our lead programmes. Currently available
topical formulations of native testosterone have significant
compliance and potential safety issues while, to date, attempts to
create oral preparations of modified testosterone have resulted in
products with unacceptable pharmacokinetic variability. Therefore,
there is an unmet need for an effective oral testosterone treatment
for hypogonadism that we believe can be met by our oral proprietary
formulation. We look forward to reporting data from this important
proof-of-concept study in patients in mid-2017."
DITEST - a proprietary lipid based formulation to overcome the
fast metabolism of native testosterone
DITEST is a novel formulation developed by Diurnal comprising
native testosterone adapted for oral delivery for the treatment of
hypogonadism. The main challenge with oral delivery of native
testosterone is that, whilst the hormone undergoes rapid and
complete absorption, there is considerable metabolism in both the
gut wall and during first hepatic pass which accounts for up to 98%
reduction in testosterone bioavailability. Diurnal's approach is a
proprietary lipid based formulation that aims to provide improved
bioavailability. Patents protecting DITEST have already been
granted in the US, Europe and other major territories
worldwide.
Proof-of-concept trial will evaluate pharmacokinetics, safety
and tolerability of DITEST
This proof-of-concept, randomised trial, which builds on the
Company's successful in vivo pre-clinical studies, will evaluate
the pharmacokinetics, safety and tolerability of DITEST in both fed
and fasted states compared to testosterone undecanoate (an approved
oral modified testosterone treatment) in 24 adult men with primary
or secondary hypogonadism. The trial is scheduled to complete by
mid-2017.
The primary endpoint of the trial will compare the rate and
extent of absorption of testosterone from a single dose of DITEST
with a single dose of 80 mg testosterone undecanoate in the fed
state in adult male patients with primary or secondary
hypogonadism. The secondary endpoints will assess the impact of
food on the rate and extent of absorption of testosterone from
DITEST and to assess the safety and tolerability of two different
doses of DITEST.
Hypogonadism - a large but fragmented multi-billion dollar
market
Hypogonadism results from failure of the testes (primary gonadal
failure) or from failure of stimulation by the pituitary (secondary
hypogonadism) resulting in testosterone insufficiency. In primary
hypogonadism, failure of the testes can be congenital (inherited)
or acquired during life due to a variety of causes (failure of the
testes to descend into the scrotum, inflammation due to infections
such as mumps, chemotherapy or radiotherapy affecting the testes,
and following removal of the testes for testicular tumours).
Secondary hypogonadism usually results from a benign tumour of the
pituitary gland that causes hypopituitarism and may occasionally be
congenital.
The hypogonadism market is a large and fragmented market. In
Europe and the US, it is primarily driven by topical formulations,
which Diurnal estimated to be of a value of $5.8 billion in 2015.
Topical formulations are the current market leaders due to low
bioavailability of testosterone in the body. However, these topical
formulations have compliance and potential safety issues; there is
therefore a need for an oral (native) testosterone preparation.
Current treatment for hypogonadism is testosterone replacement
therapy via intramuscular injections, testosterone patches and
testosterone gels. The only currently available oral forms are
therapies that present well-documented significant pharmacokinetic
variability.
For further information, please visit www.diurnal.co.uk
or contact:
+44 (0)20 3727
Diurnal Group plc 1000
Martin Whitaker, CEO
Ian Ardill, CFO
Numis Securities Ltd (Nominated +44 (0)20 7260
Adviser) 1000
Nominated Adviser: Michael Meade,
Freddie Barnfield, Paul Gillam
Corporate Broking: James Black
+44 (0)20 3727
FTI Consulting 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About DITEST
DITEST is a novel formulation developed by Diurnal comprising
native testosterone adapted for oral delivery for the treatment of
hypogonadism. The main challenge with oral delivery of native
testosterone is that, whilst the hormone undergoes rapid and
complete absorption, there is considerable metabolism in both the
gut wall and during first hepatic pass which accounts for up to 98%
reduction in testosterone bioavailability. Diurnal's approach is a
proprietary lipid based formulation that aims to provide improved
bioavailability. An additional potential feature of the native
testosterone formulation demonstrated in preclinical studies is
that it shows similar absorption in both the fed and fasted state
and therefore potentially can be taken without a substantial meal,
which is a problem associated with alternative oral
modified-testosterone formulations.
Patents protecting DITEST have already been granted in the US,
Europe and other major territories worldwide.
About Diurnal Group plc
Founded in 2004, Diurnal is a UK-based specialty pharma company
developing high quality products for the global market for the
life-long treatment of chronic endocrine conditions, including
Congenital Adrenal Hyperplasia and Adrenal Insufficiency. Its
expertise and innovative research activities focus on
circadian-based endocrinology to yield novel product candidates in
the rare and chronic endocrine disease arena.
For further information about Diurnal, please visit
www.diurnal.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
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