TIDMMPH
RNS Number : 7495K
Mereo BioPharma Group plc
17 December 2018
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED UNDER
THE MARKET ABUSE REGULATION (EU) NO. 596/2014. UPON PUBLICATION OF
THIS ANNOUNCEMENT THIS INFORMATION IS NOW CONSIDERED IN THE PUBLIC
DOMAIN.
Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Mereo BioPharma Announces Positive Results from the Safety
Extension Study to the Phase 2b clinical trial of BGS-649 for the
Treatment of Hypogonadotropic Hypogonadism in Obese Men
London, 17 December 2018 - Mereo BioPharma Group plc (AIM: MPH),
a clinical stage, UK-based, biopharmaceutical company focused on
rare and specialty diseases, announced positive data from the
safety extension study to its phase 2b clinical trial of BGS-649
for the treatment of hypogonadotropic hypogonadism (HH) in men with
a body mass index of over 30. BGS-649 is a once weekly oral
aromatase inhibitor designed to restore a patient's own
testosterone to normal levels by inhibiting the conversion of
testosterone to oestradiol. The Company previously reported
positive headline data from the phase 2b clinical trial in March
2018, with the drug meeting primary and secondary endpoints with
high statistical significance following 6 months treatment. The
safety extension study enrolled 143 patients, with 88 patients
completing the additional six months of treatment.
This safety extension study was designed to examine if BGS-649
resulted in a pre-specified reduction in bone mineral density (BMD)
at 48 weeks following the initial 24 weeks treatment. The primary
end point of this safety extension study was decrease in BMD. The
study was successful in demonstrating that none of the doses of
BGS-649 met the lower bound (95% confidence interval) of the
pre-specified safety criterion of a greater than 3% reduction in
lumbar spine BMD after 48 weeks of treatment. Consistent with this
finding, none of the doses of BGS-649 met the secondary safety
endpoint criterion of a greater than 3% reduction in bone mineral
density in the hip (total or femoral neck). In addition, there was
no shift into clinical categories of osteopenia or osteoporosis,
with no evidence of development of new osteopenia.
Consistent with the top-line data announced by Mereo in March
2018, treatment with BGS-649 resulted in normalization of total
testosterone levels in over 75% of subjects at all three doses
tested at the end of the six months extension study period (this
measure was the primary endpoint in the placebo-controlled portion
of the trial). Similarly, normalization of testosterone in at least
90% of patients (a key secondary endpoint of the placebo-controlled
portion of the trial) occurred at all three doses (versus at the
two highest doses in the initial 6 months). All three doses also
continued to meet all other secondary endpoints, including the
improvement of testosterone luteinising hormone (LH) and follicle
stimulating hormone (FSH) levels. The extension study continued to
demonstrate a clear dose-response in both the primary and secondary
endpoints. The total motile sperm count was not determined in this
extension study and the company is continuing to analyse the data
from the exploratory patient reported outcomes (PROs).
The adverse event profile in the extension study, where all
patients received one of the three doses of BGS-649 for 6 months
was similar to that seen in patients receiving the drug in the
placebo controlled portion of the trial. There was an increased
incidence of raised haematocrit levels in patients receiving
BGS-649 and small increases in blood pressure at the two highest
doses consistent with increasing testosterone.
Dr. Denise Scots-Knight, Chief Executive Officer of Mereo
commented:
"We are pleased that the results of our six-month extension
study reiterate the positive top-line results we announced earlier
this year. The extension data provides further evidence of the
potential of BPS-649. Following further data analysis in 1H 2019 we
will confirm our plans for the late stage clinical development of
this promising drug as we also consider potential
partnerships."
About the Phase 2b study and six-month extension study
The Phase 2b dose-confirmation study, which commenced in 2016,
was a randomized, double-blind, placebo-controlled clinical trial
assessing three different dosing regimens of BGS-649 in 271 obese
men with HH. Following baseline assessment, patients were
randomized to receive one of three weekly doses of BGS-649 or
placebo for 24 weeks. The primary endpoint was normalization of
total testosterone levels in greater than 75% of subjects after 24
weeks of treatment. Secondary measures included determining the
impact of BGS-649 on the levels of testosterone LH and FSH, as well
as normalization of total testosterone in greater than 90% of the
subjects after 24 weeks of treatment. Exploratory end points
included semen parameters and patient reported outcomes (PROs). At
the end of the initial 24-week treatment period, patients had the
option to enrol into a six-month safety extension study in which
they received the same dose or in the case of placebo patients,
were randomized to one of the three doses. Patients continued to be
monitored for LH and FSH levels and bone mineral density. The Phase
2b safety extension study enrolled 143 patients, with 88 patients
completing the six-month safety extension study.
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; 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
Ami Bavishi
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END
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