Diurnal Group PLC Phase 1 data for DITEST published in EJE (5774O)
11 Octubre 2021 - 1:00AM
UK Regulatory
TIDMDNL
RNS Number : 5774O
Diurnal Group PLC
11 October 2021
11 October 2021
Diurnal Group plc
("Diurnal" or the "Company")
Phase 1 data for DITEST(TM) published in European Journal of
Endocrinology
US IND submission for the Company's third novel product expected
in Q4 2021
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that the results from the Company's Phase 1
clinical trial for its development product DITEST(TM) (native oral
testosterone formulation) as a treatment for male primary and
secondary hypogonadism have been published in the peer-reviewed
European Journal of Endocrinology.
DITEST(TM) is the Company's third product and is a native oral
testosterone therapy in development for the treatment of male
hypogonadism. The Company's Phase 1 study (DITEST-001) evaluated
the pharmacokinetics, safety and tolerability of a single dose of
native oral testosterone in 24 adult men with primary or secondary
hypogonadism demonstrating the achievement of testosterone levels
within the healthy young male adult normal range after oral
administration.
Secondary endpoints of the study demonstrated that there was no
impact on the rate and extent of absorption of testosterone from
DITEST(TM) whether taken with either food or in the fasted state,
representing a major difference from testosterone undecanoate.
There were no serious adverse events in the DITEST(TM) arm of the
study, and levels of the potent testosterone derived androgen,
dihydrotestosterone (DHT), were lower than seen with testosterone
undecanoate. The article in the European Journal of Endocrinology
concludes that dosing independent of food and a lower risk of
supraphysiological DHT levels may be advantages for patients with
hypogonadism.
The European Journal of Endocrinology article, entitled "An oral
lipidic native testosterone formulation that is absorbed
independent of food" can be accessed here:
https://eje.bioscientifica.com/view/journals/eje/185/5/EJE-21-0606.xml
.
Professor Richard Ross, a founding Director and Chief Scientific
Officer of Diurnal, commented:
"We are pleased to have the results from our Phase 1 clinical
trial of DITEST(TM) published in a leading peer-reviewed
endocrinology journal as we continue to progress the development of
our third product. This paper reinforces our beliefs that
DITEST(TM) could be an effective and differentiated therapy to
address the significant unmet patient needs of the 60 million men,
globally, who are affected by hypogonadism. The Company looks
forward to submitting an Investigational New Drug Application to
the US Food and Drug Administration shortly."
This is a business press release containing financial
information and/or data for the benefit of shareholders and
potential investors. Data are included to allow informed investment
decisions.
For further information, please visit www.diurnal.co.uk or
contact:
+44 (0)20 3727
Diurnal Group plc 1000
Martin Whitaker, Chief Executive Officer
Richard Bungay, Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser +44 (0)20 7886
and Sole Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: Rupert Dearden
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Alex Davis
Notes to Editors
About Hypogonadism
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.
Diurnal estimates that in Europe and the US the market opportunity
is around $5 billion per annum. Topical (gel) formulations are the
current market leaders due to low bioavailability of testosterone
in the body when administered by the oral route. However, these
topical formulations have compliance and administration issues.
Other testosterone replacement therapies for hypogonadism include
intramuscular injections, testosterone patches and the only
currently available oral forms are modified testosterones (such as
testosterone undecanoate) that have limited label scope,
well-documented pharmacokinetic variability, a requirement to be
taken with a high fat meal and safety concerns.
Therefore, Diurnal believes that there is a patient need for an
oral (native) testosterone preparation.
About DITEST(TM)
DITEST(TM) 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 (the amount of drug in
the body that is able to have an active effect). Diurnal's approach
is a proprietary lipid-based formulation that aims to provide
improved bioavailability of testosterone. An additional potential
feature of the native testosterone formulation demonstrated in both
preclinical studies and now in this clinical study is that it shows
similar absorption and bioavailability in both the fed and fasted
state and therefore potentially can be taken without a substantial
meal, which is a requirement with many alternative oral
modified-testosterone formulations.
Patents protecting DITEST(TM) have already been granted in the
US, Europe and other major territories worldwide.
About Diurnal Group plc
Diurnal Group plc is a European, UK-headquartered, specialty
pharmaceutical company dedicated to developing hormone therapeutics
to aid lifelong treatment for rare and chronic endocrine
conditions, including congenital adrenal hyperplasia, adrenal
insufficiency, hypogonadism and hypothyroidism. 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
Date of Preparation: October 2021 Code: CORP-GB-0158
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