TIDMMPH
RNS Number : 0671F
Mereo BioPharma Group plc
15 May 2017
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Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Update on acumapimod Phase 2 Study
Completion of Patient Enrolment of a Phase 2 Dose-Ranging
Study
of acumapimod for the treatment of AECOPD
Top line results expected H2 2017
London, 15 May 2017 - Mereo BioPharma Group plc (AIM: MPH), a
clinical stage, UK-based, biopharmaceutical company focused on rare
and specialty diseases, today announced, that it has successfully
completed patient enrolment in the AETHER, multi-centre,
double-blind, placebo-controlled Phase 2 dose-ranging study of
acumapimod (BCT-197), for the treatment of patients with acute
exacerbations of chronic obstructive pulmonary disease (AECOPD).
Acumapimod is a novel, orally active p38 MAP kinase inhibitor in
development as a first-line acute therapy for AECOPD.
A total of 282 patients have been enrolled to explore two
different dosing regimens versus placebo, on top of standard of
care, in patients presenting with an AECOPD in the hospital
setting. The study aims to determine the most appropriate dosing
regimen of acumapimod. The primary end point is forced expiratory
volume in one second (FEV1). Following a 5-day dosing period,
patients are being followed for 26 weeks to explore a number of
additional end points including hospital stay times, patient
reported outcomes and recurrence rates of AECOPD. Top-line data
from this study is expected in the second half of 2017.
Alastair Mackinnon, Chief Medical Officer of Mereo BioPharma
Group plc commented:
"This is another important milestone in our strategy of rapidly
developing our portfolio of assets acquired from big pharma,
following on from the recent initiation of a potentially pivotal
Phase 2b study for BPS-804 in the orphan disease osteogenesis
imperfecta. COPD is a chronic and debilitating condition,
characterised by acute exacerbations which can result in
hospitalisation and accelerate long term lung function decline. The
treatment paradigm for AECOPD has not advanced in over a decade in
the US or Europe and there is a growing need for new therapies. In
previous Novartis studies, acumapimod was shown to have a
statistically significant and clinically meaningful impact on FEV1
in AECOPD patients and to be a powerful anti-inflammatory. We
believe it has the potential to be an important new treatment to
improve the quality of life of these patients whilst also reducing
healthcare costs."
About acumapimod (BCT-197)
Acumapimod is an orally active p38 MAP kinase inhibitor in
development as a first-line acute therapy, alongside existing
treatment for AECOPD. p38 MAP kinase is central in the acute
inflammatory pathway. It is rapidly activated in response to viral
and bacterial infections, pollutants and other noxious agents which
are the key drivers of acute inflammation underlying the pathology
of COPD exacerbations. p38 is activated in COPD and AECOPDs and is
inversely correlated with measure of lung function. The higher the
p38 MAP kinase activation, the lower lung function is expected to
be. COPD patients are usually treated with corticosteroids to
control the inflammation including during exacerbations. Steroid
resistance however, is common and despite this treatment, there
remains a considerable unmet need for improved management and
outcome from AECOPDs . Mereo believes acumapimod, through targeting
the pathways that drive the pathological mechanism behind acute
exacerbations, offers a potential new treatment for controlling the
inflammation.
Previous studies undertaken by Novartis, showed acumapimod
demonstrated a statistically significant reduction of the
inflammatory marker TNF<ALPHA> and a clinically meaningful
increase in forced expiratory volume in one second (FEV1), a
clinically relevant endpoint in the treatment of COPD. In studies
to date, acumapimod has been shown to be safe and well tolerated in
the target patient population.
About AECOPD
Chronic obstructive pulmonary disease (COPD) is a
non-reversible, progressive lung disease that is estimated to
affect 210 million people world wide(1) and is a leading cause of
death. An AECOPD is characterised by a sudden worsening in the COPD
patient's symptoms of dyspnoea, cough and sputum production. Acute
exacerbations last for several days and require a step up of
medication and often hospitalisation. AECOPDs occur in the natural
course of the disease and are commonly triggered by infections and
air pollution. Both airway and systemic inflammation are
characteristic drivers of the disease
(1 Epidemiology and Prevalence of Chronic Obstructive Pulmonary
Disease, Enrique Diaz-Guzman, MD, David M. Mannino, MD March 2014,
Clinics in Chest Medicine)
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 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 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 AECOPD; and BGS-649 is a once-weekly pill to
restore normal testosterone levels in men with hypogonadotropic
hypogonadism.
In H1 2016 the Company initiated a Phase 2 study with acumapimod
and a Phase 2b study with BGS-649. Mereo recently announced
commencement of the first pivotal trial for BPS-804. 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
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