TIDMMPH
RNS Number : 1521Z
Mereo BioPharma Group plc
13 December 2017
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Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Business Update
Continued clinical development progress across all
programmes
London, 13 December 2017 - Mereo BioPharma Group plc (AIM: MPH),
a multi-asset biopharmaceutical company focused on the acquisition,
development and commercialisation of innovative therapies that aim
to improve outcomes for patients with rare and specialty diseases,
today provides an update on its clinical development pipeline in
addition to a general corporate update. The Company also announces
that it intends to publish preliminary results for its financial
year ending December 31, 2017 by the end of March 2018.
Highlights
-- Reported positive top-line data from BCT-197 (acute
exacerbations of chronic obstructive pulmonary disease) Phase 2
study, with primary endpoint met; BCT-197 also demonstrated
statistically significant reduction in number of rehospitalisations
in high dose group and was reported to be safe and well tolerated
in both high and low dose regimens
-- Completed enrolment of BGS-649 (Hypogonadotropic Hypogonadism
in obese men) Phase 2b study and on track to deliver top-line data
in Q1 2018
-- BPS-804 (osteogenesis imperfecta) granted EMA PRIME designation
o Phase 2b trial in adult patients ongoing; following
discussions with the regulators measurement of primary endpoint for
the HRpQCT analysis changed from six to 12 months
o Paediatric Investigational Plan has been submitted to the EMA
based on a potential 12-month fracture endpoint and Phase 2b/3
study expected to start in 2018
-- AZD-9668 (alpha-1 antitrypsin deficiency) licensed from
AstraZeneca, transition progressing according to plan and Phase 2
study expected to start in 2018
-- Balance sheet remains strong:
o Unaudited cash and short term deposit balances of GBP46.8
million as at November 30, 2017
o Second and final GBP10m (gross) tranche of GBP20m credit
facility agreed with Silicon Valley Bank and Kreos Capital in
August 2017 expected to be drawn down prior to end of 2017
-- Continue to evaluate additional opportunities to expand
portfolio especially in rare diseases
Dr Denise Scots-Knight, Chief Executive Officer of Mereo
BioPharma Group plc commented:
"We have continued to make strong progress on our diversified
product candidate pipeline throughout the year. This has culminated
in the recent release of positive headline results from the Phase 2
clinical study of BCT-197 in acute exacerbations of COPD and the
recently announced license of AZD-9668. We look forward to
delivering the top-line Phase 2b clinical data for BGS-649 in
hypogonadotropic hypogonadism in Q1 2018 and to initiating the
Phase2b/3 paediatric study for our orphan product candidate BPS-804
in osteogenesis perfecta and the Phase 2 proof of concept study for
AZD-9668 for the treatment of alpha-1 antitrypsin deficiency."
Pipeline update
BCT -197 (Acumapimod) for acute exacerbations of COPD
(AECOPD)
On December 11, 2017 the Company announced positive top-line
data from the AETHER study, a Phase 2 double-blind, randomised,
placebo-controlled trial investigating the use of BCT-197, a novel,
orally active p38 MAP kinase inhibitor, on top of Standard of Care,
for the treatment of patients with AECOPD. The primary endpoint was
met on an ITT basis for both BCT-197 high and low dose regimens (p=
0.012, p <= 0.001) with no significant change from baseline
(p=0.102) shown for Standard of Care plus placebo. One of the study
objectives was the comparison between all three groups. This was
not statistically significant; however, the treatment arms were
numerically superior to the Standard of Care plus placebo arm.
Positive clinical and health economic outcomes were supported by
other secondary measures; specifically, the study showed a
statistically significant reduction of more than 50% (p <= 0.027
to 0.05) in the number of clinical treatment failures in the high
dose group compared to Standard of Care plus placebo, as measured
by the number of rehospitalisations for the treatment of COPD at
days 90 through 150, and there was a trend seen as early as day 30.
BCT-197 was reported to be safe and well tolerated in both high and
low dose regimens. The Company now intends to seek a partner for
future development and, if approved, commercialisation of
BCT-197.
BGS-649 (leflutrozole) for the treatment of hypogonadotropic
hypogonadism (HH) in obese men
The Company is on track to announce top-line data in Q1 2018
from the randomised, placebo-controlled Phase 2b dose-confirmation
study with BGS-649 for the treatment of HH in obese men, which
successfully completed patient enrolment in September 2017. A total
of 271 patients have been enrolled into the six-month study,
assessing three different doses versus placebo. The primary
endpoint of this study is to demonstrate the efficacy of BGS-649 to
normalise total testosterone levels in over 75% of subjects after
24 weeks of treatment. A six-month extension study in up to 120
patients to confirm the safety of long term treatment with BGS-649
is well underway. In March 2017 the Company announced that the
Independent Data Monitoring Committee recommended continuation of
all the arms of the study based on a blinded interim review of the
safety and efficacy of all three doses based on 93 patients who had
received at least one month's treatment.
BPS-804 (setrusumab) for osteogenesis imperfecta (brittle bone
disease, or OI)
In November 2017, following acceptance into the EMA's adaptive
pathways programme, our orphan product candidate BPS-804 was
granted EMA PRIME designation for the treatment of OI. The
potentially pivotal Phase 2b ASTEROID study with BPS-804 is
currently underway in which we intend to enroll approximately 120
adult patients with OI. The primary endpoint is change in
trabecular volumetric bone mineral density measured by high
resolution peripheral quantitative CT (HRpQCT) and change in bone
strength using finite element analysis (FEA). As previously
announced, the Company is planning an additional study in
paediatric OI patients and has recently submitted its Paediatric
Investigation Plan (PIP) for BPS-804 to the Paediatric committee of
the European Medicines Agency (PDCO), including an initial Phase
2b/3 potential 12-month fracture study in children 12 to less than
18 years old. As a result of these discussions, the Company has
also changed the primary endpoint for the HRpQCT analysis in the
ongoing adult clinical study from six months to 12 months.
AZD-9668 (alvelestat) for alpha-1 antitrypsin deficiency
(AATD)
In October 2017, the Company announced an exclusive license
agreement with AstraZeneca for AZD-9668, an oral inhibitor of
neutrophil elastase, with an option to acquire the product
candidate following the initiation of pivotal studies. The transfer
of the program from AstraZeneca is progressing as planned and Mereo
expects to initiate a Phase 2 study for the treatment of severe
AATD, a congenital orphan condition, in 2018. This Phase 2 study is
expected to be a 12-week randomized, placebo-controlled study that
will evaluate two doses of AZD-9668 in approximately 150 patients
with the PiZZ and NULL genetic mutations. These mutations are seen
in the more severely affected AATD patients who have very low
(PiZZ) or zero (NULL) alpha-1 antitrypsin levels. Following
completion of the transaction, AstraZeneca has become a shareholder
in Mereo.
Corporate update
Strong balance sheet
The Company's balance sheet remains strong, with sufficient cash
resources to fund the key clinical development programmes. As at
November 30, 2017, the Company had unaudited cash and short term
deposit balances of GBP46.8 million. The Company has notified
Silicon Valley Bank and Kreos Capital of its intention to draw down
the GBP10m (gross) second and final tranche of the GBP20m credit
facility finalised and previously announced in August 2017. This
will increase our cash resources and is expected to complete prior
to the year end. On drawdown, the Company will issue warrants
giving the lenders the right to subscribe for shares representing
11% of the value of the drawn amount which is currently equivalent
to approximately 0.5% of the issued share capital of the Company.
These warrants, when issued, will be capable of exercise until
August 7, 2027.
Continued evaluation of new product candidate opportunities
Mereo is focused on building a leading commercial business in
rare and orphan diseases. The Company continues look for
opportunities to further expand and diversify its product portfolio
and is evaluating a number of innovative clinical stage products
for the potential treatment of rare diseases from large
pharmaceutical and biotechnology companies.
For Further Enquiries:
Mereo BioPharma Group plc +44 (0)333 023 7319
Denise Scots-Knight, Chief
Executive Officer
Richard Jones, Chief Financial
Officer
Nominated Adviser and Joint
Broker
Cantor Fitzgerald Europe +44 (0)20 7894 7000
Phil Davies
Will Goode
Joint Broker
RBC Capital Markets +44 (0)20 7653 4000
Rupert Walford
Laura White
Public Relations Adviser to
Mereo
FTI Consulting +44 (0)20 3727 1000
Ben Atwell
Simon Conway
Brett Pollard
US Public Relations Advisor
to Mereo +01 (0) 212 213
Burns McClellan 0006
Lisa Burns
Steven Klass
About Mereo
Mereo is a multi-asset biopharmaceutical company focused on the
acquisition, development and commercialisation of innovative
therapeutics that aim to improve outcomes for patients with rare
and specialty diseases. The portfolio consists of four
clinical-stage product candidates, each of which we acquired from
large pharmaceutical companies: BPS-804 for the treatment of
osteogenesis imperfecta, or OI; AZD-9668 for the treatment of
severe alpha-1 antitrypsin deficiency, or AATD; BGS-649 for the
treatment of hypogonadotropic hypogonadism, or HH, in obese men;
and BCT-197 for the treatment of acute exacerbations of chronic
obstructive pulmonary disease, or AECOPD. Each of the company's
product candidates has generated positive clinical data for the
target indication or in a related disease. The company's strategy
is to selectively acquire product candidates that have already
received significant investment from pharmaceutical companies and
that have substantial preclinical, clinical and chemistry,
manufacturing and controls, or CMC, data packages. Since inception,
the company has commenced large, randomized, placebo-controlled
Phase 2 clinical trials for three of the product candidates. The
company intends to commence additional late-stage clinical trials
in 2018.
This information is provided by RNS
The company news service from the London Stock Exchange
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