Mereo BioPharma Group plc BGS-649 Phase 2b data to be Presented at ENDO 2019 (0697N)
15 January 2019 - 6:00PM
UK Regulatory
TIDMMPH
RNS Number : 0697N
Mereo BioPharma Group plc
15 January 2019
Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
BGS-649 Phase 2b data to be Presented at ENDO 2019
London, 15 January 2019 - Mereo BioPharma Group plc (AIM: MPH),
a clinical stage, UK-based, biopharmaceutical company focused on
rare and specialty diseases, is pleased to announce that the
abstract, entitled 'Beneficial Effect on Sperm Production of
Leflutrozole in Men with Obesity-Associated Secondary
Hypogonadotropic Hypogonadism: Results from a Phase II Study' will
be presented by Professor Hugh Jones, Barnsley Hospital NHS
Foundation Trust and the University of Sheffield at ENDO 2019 in
New Orleans, LA on 24 March 2019 from 10.00am to 12.00pm CST.
The oral presentation will focus on sperm production data from
Mereo's Phase 2b in men with obesity-associated secondary
hypogonadotropic hypogonadism.
The title, timing and location of the presentation is as
follows:
Abstract Number: 5742
Title: Beneficial Effect on Sperm Production of Leflutrozole
in Men with Obesity-Associated Secondary Hypogonadotropic
Hypogonadism: Results from a Phase II Study
Day/Date: Sunday 24 March 2019
Time: 10.00am to 12.00pm CST
Session: OR18. Male Gonadal Function
Session Type: Oral Session
Abstracts will be published online no later than 31 January
2019. You may view the abstract after 31 January by searching for
Mereo on the ENDO web program at
https://www.abstractsonline.com/pp8/#!/5752
About Hypogonadotropic Hypogonadism
Hypogonadotropic hypogonadism results from inadequate levels of
testosterone. Symptoms associated with testosterone deficiency
include reduced/loss of libido, erectile dysfunction, tiredness,
fatigue, impaired physical endurance, loss of vitality, lack of
motivation and mood disturbance. There are approximately seven
million cases of HH in obese men in the US and approximately five
million cases in Europe. Current therapies for HH involve direct
replacement of testosterone administered by gel formulations
applied to the skin, which risk transference to anyone in close
contact, patches or intramuscular injections, which can be painful
and inconvenient. Direct exogenous testosterone replacement can
also impair male fertility by suppressing LH and FSH.
About BGS-649
BGS-649 is a once a week oral treatment for HH in obese men,
that restores a patient's own testosterone. It is a novel aromatase
inhibitor that inhibits conversion of the patients' own
testosterone to oestradiol, thereby increasing testosterone levels.
BGS-649 is designed to be more convenient compared with current
therapies and due to its mechanism of action restores normal
testosterone production without the risk of supra-physiological
levels or suppression of LH and FSH, thereby treating the symptoms
of HH whilst maintaining or improving testicular function.
About Mereo
Mereo is a biopharmaceutical company focused on the development
and commercialization of innovative therapeutics that aim to
improve outcomes for patients with rare diseases. Mereo's strategy
is to selectively acquire product candidates that have already
received significant investment from pharmaceutical companies and
that have substantial preclinical, clinical and manufacturing data
packages. In December 2018, Mereo announced the proposed
combination of Mereo and OncoMed Pharmaceuticals Inc., with the
transaction expected to close in the first half of 2019. Each of
Mereo's four product candidates has previously generated positive
clinical data for Mereo's target indication or in a related
indication. Since inception Mereo has commenced large, randomized,
placebo-controlled Phase 2 clinical trials for all four of the
product candidates:
-- BPS-804 for osteogenesis imperfecta (OI). The Company
recently announced completion of enrolment with 112 adult patients
in a Phase 2b dose ranging study with some initial data expected in
the H1 2019 and top-line dose ranging data in late 2019. A
pediatric Phase 3 study design has also been approved by the EMA.
BPS-804 has orphan designation in the US and EU and has been
accepted into the PRIME and Adaptive Pathways in EU;
-- MPH-966 for alpha-1 antitrypsin deficiency (AATD). The
Company recently announced first patient in in a Phase 2 dose
ranging study in the US with data expected in late 2019;
-- BCT-197 for acute exacerbations of COPD (AECOPD). The Company
presented positive Phase 2 data at the American Thoracic Society in
May, 2018;
-- BGS-649 for hypogonadotropic hypogonadism (HH). The Company
announced positive top-line Phase 2b data in March 2018. Positive
data from the safety extension study to the Phase2b clinical trial
was announced in December 2018; and
-- As at September 30, 2018 Mereo had (unaudited) total cash
resources of approximately US$44.6 million
For Further Enquiries:
Mereo +44 (0)333 023 7300
Denise Scots-Knight, Chief Executive Officer
Richard Jones, Chief Financial Officer
Cantor Fitzgerald Europe (Nominated Adviser
and Joint Broker to Mereo) +44 (0)20 7894 7000
Phil Davies
Will Goode
RBC Capital Markets (Joint Broker to Mereo) +44 (0)20 7653 4000
Rupert Walford
Jamil Miah
FTI Consulting (Public Relations Adviser to
Mereo)
Simon Conway +44 (0)20 3727 1000
Brett Pollard
Burns McClellan (US Public Relations Adviser
to Mereo) +01 (0) 212 213 0006
Lisa Burns
Jill Steier
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END
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