Mereo BioPharma Group plc Positive Phase 1 interaction study with BCT-197 (1958O)
03 November 2016 - 6:00PM
UK Regulatory
TIDMMPH
RNS Number : 1958O
Mereo BioPharma Group plc
03 November 2016
Mereo BioPharma Group plc
("Mereo" or the "Company")
Positive Phase 1 interaction study with BCT-197 (acumapimod)
London, 3 November 2016 - Mereo BioPharma Group plc (AIM: MPH),
a clinical stage, UK-based, biopharmaceutical company focused on
rare and specialty diseases, today announces the positive outcome
of its Phase 1 drug interaction study with acumapimod, the active
compound in the Company's novel p38 MAP kinase inhibitor BCT-197.
BCT-197 is currently in a Phase 2 study for the treatment of acute
exacerbations of COPD (AECOPD).
This study evaluated potential drug interactions between
acumapimod and the antibiotic azithromycin. The study confirmed no
drug interaction or evidence of adverse effects on safety and
tolerability, meaning acumapimod may therefore be dosed with
azithromycin.
Dr Alastair Mackinnon, Chief Medical Officer of Mereo, said "We
are delighted to announce the results of our Phase 1 drug
interaction study. Patients with COPD frequently use azithromycin
in the management of acute exacerbations and some use it as a
maintenance therapy for their disease. The results of this study
are encouraging as they remove restrictions on patients already
taking azithromycin for the ongoing clinical programme and allow
physicians to use this common antibiotic in the management of
AECOPDs alongside BCT-197."
ENDS
About BCT-197(acumapimod)
BCT-197 is an orally active p38 MAP kinase inhibitor being
developed as first-line acute therapy alongside existing treatment
and supportive care for AECOPD. The ongoing Phase 2 study is
planned to enroll 270 patients in the US and EU and is designed to
study different dosing regimes of BCT-197 on top of standard of
care in patients presenting with an AECOPD in the hospital setting.
The primary end point is lung capacity, as measured by FEV1, with a
range of exploratory secondary end points including hospital stay
times, patient reported outcomes and re-exacerbation rates during a
six month follow-up period.
About AECOPD
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, however one third do not have an identifiable
trigger. Both airway and systemic inflammation are characteristic
drivers of the disease
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);
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 BCT-197
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 trial during H1
2017, pending feedback from the regulator. Additional product
opportunities, from a range of large pharmaceutical companies, are
under active evaluation.
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
This information is provided by RNS
The company news service from the London Stock Exchange
END
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