TIDMMPH
RNS Number : 5135R
Mereo BioPharma Group plc
12 December 2016
Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Business Update
Significant clinical progress; on track to deliver key value
inflection points in 2017
London, December 12 2016 - Mereo BioPharma Group plc (AIM: MPH),
a clinical stage, UK-based, biopharmaceutical company focused on
rare and specialty diseases, is pleased to provide an update on its
three clinical development programmes 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, 2016 on February 27, 2017.
Highlights
-- First potential pivotal study for BPS-804 (osteogenesis
imperfecta) expected to start in H1 2017
-- On track to deliver data in H2 2017 from Phase 2 studies for
acumapimod (AECOPD) and BGS-649 (hypogonadal hypogonadism)
-- Outcome of the interim blinded analysis of the BGS-649 study
to potentially eliminate ineffective dose levels, expected Q1
2017
-- Strengthened the intellectual property protection across the portfolio
-- Balance sheet remains strong, with unaudited cash balance of
GBP57.9 million as of 30 November 2016
-- Evaluating additional opportunities to strengthen our rare and specialty disease portfolio
Pipeline update
BPS-804 for osteogenesis imperfecta (brittle bone disease)
Following feedback from the regulators, the first potential
pivotal study for orphan drug BPS-804, an anti-sclerostin antibody,
in patients with osteogenesis imperfecta (OI) is expected to
commence in H1 2017. This will be a randomised, placebo controlled,
dose-ranging study enrolling at least 120 patients with Type I,
Type III or Type IV OI. The primary endpoint will be based on
high-resolution peripheral quantitative computed tomography
(HR-pQCT) images, a novel 3D image processing technique that can be
used to assess bone quality and strength. Data will be collected at
six and twelve months following the commencement of treatment. Bone
mineral density (BMD; measured by Dual-energy X-ray absorptiometry
(DEXA)), bone biomarkers and several patient reported outcomes
(PROs) will also be measured. Interim efficacy data from this
study, following six months treatment, are now expected to be
available in H1 2018.
Acumapimod (BCT -197) for acute exacerbations of COPD
(AECOPD)
The Phase 2 dose-ranging study with acumapimod, a p38 MAP kinase
inhibitor, for treatment of the underlying inflammation in patients
with acute exacerbation of COPD (AECOPD) is on track to deliver
data in H2 2017. The study is recruiting 255 AECOPD patients to
assess the impact of two different dose levels versus placebo on
top of existing standard of care.
BGS-649 for the treatment of hypogonadal hypogonadism (HH)
The Phase 2b dose-confirmation study with the once-weekly,
orally administered, aromatase inhibitor, BGS-649, for the
treatment of symptomatic HH in obese men, is on track to deliver
data in H2 2017. The study is recruiting 260 patients with HH to
assess three different dose levels compared to placebo. The primary
objective of this trial is to demonstrate the normalisation of
testosterone in a significantly greater percentage of patients
receiving BGS-649 compared to those receiving placebo and to
establish the lowest effective dose of BGS-649. The Company is also
examining several PROs in the trial. Results of an interim blinded
analysis, to potentially eliminate any dose that has not normalised
testosterone levels, are expected in Q1 2017.
The Company has started enrolling patients who have previously
been treated for six months with BGS-649 in the Phase 2b dose
confirmation study into the six month Phase 2b extension study, to
assess the safety of longer-term treatment with BGS-649. This study
is expected to recruit up to 120 patients.
The Company attended the FDA Advisory Committee on secondary
hypogonadism on 6(th) December 2016 and was encouraged that the FDA
and the Committee recognised the unmet medical need and the need to
study symptomatic patients in clinical trials.
Corporate update
Balance Sheet remains strong
The Company's balance sheet remains strong, with sufficient cash
to fund the key clinical milestones which the Company believes will
be significant value inflection points. As of 30 November 2016 the
Company had an unaudited cash balance of GBP57.9 million.
Intellectual property portfolio strengthened
The Company has expanded its intellectual property protection
across the portfolio through both new patent applications and the
grant of pending patent applications for acumapimod, BPS-804, and
BGS-649 in the US, EU and other territories.
Triaging additional opportunities in rare and specialty
diseases
A key part of Mereo's strategy is to expand its portfolio of
innovative clinical stage products in areas where there is high
unmet medical need. The Company continues to evaluate additional
potential candidates in rare and specialty diseases, which have
strong scientific rationale and a clear path to significant value
generating inflection points, from a number of large pharmaceutical
and biotechnology companies.
Dr Denise Scots-Knight, Chief Executive Officer of Mereo
BioPharma Group plc, commented:
"We continue to make substantial progress in the clinical
development of our initial product portfolio following the formal
launch of the Company just under a year and a half ago. We remain
focused on delivering a number of significant value inflection
points as we look forward to 2017.
"In line with our stated strategy, and with all three acquired
programmes in the clinic in 2017, we are evaluating additional
opportunities to strengthen our rare and specialty disease
portfolio and remain in discussions with a number of large
pharmaceutical and biotechnology companies. We believe our novel
business model aligns our interests with the drug development needs
of these organisations where significant internal prioritisation
for strategic and capital allocation reasons limits their ability
to fund their entire pipeline of research and development stage
assets.
"We remain confident that we are well positioned to build a
scalable and sustainable speciality pharmaceutical business that
will bring forward important therapies in areas of high patient
need and will generate significant shareholder value."
For Further Enquiries:
Mereo BioPharma Group plc +44 (0)333 023 7319
Denise Scots-Knight, Chief Executive
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
Public Relations Adviser to Mereo
Biopharma
FTI Consulting +44 (0)20 3727 1000
Ben Atwell
Simon Conway
Brett Pollard
About Mereo
Mereo is a UK-based biopharmaceutical company focused on the
development of innovative medicines that aim to address unmet
medical needs in rare and specialty disease areas and improve
patient quality of life. The Company seeks to selectively acquire
development-stage product candidates with demonstrated clinically
meaningful data from large pharmaceutical companies and to rapidly
progress these product candidates to subsequent value inflection
points.
Mereo combines the operational discipline and efficiency of a
small company with the financial resources to conduct comprehensive
clinical studies. The Company has the option to directly
commercialise products, for example in orphan diseases, in addition
to partnering or divesting its products.
Mereo's initial portfolio consists of three mid-late stage
clinical assets that were acquired from Novartis in July 2015.
BPS-804 is being developed for the prevention of fractures
resulting from osteogenesis imperfecta (brittle bone disease);
acumapimod (BCT-197), is being developed to treat inflammation in
patients with an acute exacerbation of chronic obstructive
pulmonary disease; and BGS-649 is a once-weekly pill to restore
normal testosterone levels in men with hypogonadal
hypogonadism.
In H1 2016 the Company initiated a Phase 2 study with acumapimod
and a Phase 2b study with BGS-649. Mereo submitted its proposed
Phase 2b/3 pivotal study design package for BPS-804 to the
regulator in H1 2016 and expects to commence the first pivotal
trial for BPS-804 during H1 2017. Additional product opportunities,
from a range of large pharmaceutical and biotechnology companies,
are under active evaluation.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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