Mereo BioPharma Group plc Successful end of Phase 2 Meeting with FDA (1286W)
April 15 2019 - 1:00AM
UK Regulatory
TIDMMPH
RNS Number : 1286W
Mereo BioPharma Group plc
15 April 2019
Mereo BioPharma Group plc
("Mereo" or the "Company" or the "Group")
Mereo Announces Successful End of Phase 2 Meeting with FDA and
Provides Outline of Pivotal Trial Design for Acumapimod for Severe
Exacerbations of COPD
London, 15 April 2019 - Mereo BioPharma Group plc (AIM: MPH), a
clinical stage, UK-based, biopharmaceutical company focused on rare
diseases, announces that it has held a successful Type B end of
Phase 2 meeting with the U.S. Food and Drug Administration (FDA)
regarding acumapimod (BCT-197) as a treatment for the reduction of
acute exacerbations of COPD (AECOPD).
In the meeting, Mereo and the FDA discussed, and agreed in
principle, an outline for the design of a pivotal Phase 3 clinical
trial programme to support the development of acumapimod as a five
day treatment regimen for patients undergoing severe exacerbations
of COPD to reduce further exacerbations. In summary, the programme
consists of two randomised, double blind, placebo controlled
studies comparing one dosing regimen of study drug on top of
standard of care (SOC) to placebo plus SOC. The trials are expected
to enrol approximately 800 patients each. The primary end point
will be the time to next severe exacerbation/rate of severe
exacerbations. Secondary endpoints will likely include the rate of
moderate/severe exacerbations, reduction in systemic corticosteroid
exposure, all-cause hospitalisation, lung function, symptoms
measured by St Georges Health Questionnnaire (SGHQ), safety and
tolerability, including the option for re-treatment of severe
exacerbations at any point after a 14 day period following initial
dosing with follow-up to 12 months. Mereo will now work with the
FDA to finalize the pivotal Phase 3 study design.
In line with Mereo's previously stated strategy, the Company
commenced discussions with potential partners for acumapimod in
2018, which continue to progress.
Dr. Alastair MacKinnon, Chief Medical Officer said:
"We are pleased with this positive outcome from our meeting with
the FDA, where we agreed, in principle, the design of the pivotal
trial programme for acumapimod. This is a novel approach to
treating the disease as patients are dosed during an acute
exacerbation in order to reduce further exacerbations of COPD. This
builds directly on the positive data we generated in our successful
Phase 2 trial. We have previously stated our intention to partner
acumapimod and believe that the outcome of this meeting will help
us to progress these discussions."
About acumapimod
Acumapimod is a p38 MAP kinase inhibitor in development as a
therapy taken by patients with an AECOPD, in order to prevent or
reduce the number of further exacerbations. It is designed to
inhibit the pathological mechanism behind inflammation, which is a
key feature of AECOPD. The Company believes acumapimod, if
approved, offers a potential new treatment by targeting the
underlying disease and delivering tangible benefits for patients
and payers by potentially preventing AECOPD, and reducing
readmissions.
The Company believes acumapimod has the following key advantages
over current therapies:
-- Potential to be a rapid-onset treatment targeting inflammatory drivers of AECOPD
-- Designed to target anti-inflammatory response systemically
and locally with easier and more flexible oral administration than
inhaled treatments
-- Simple oral regimen of three doses over five days that can be
conveniently administered in an outpatient setting
-- Designed to target pathophysiology of acute exacerbations
without generalized immune suppression
-- Potential for efficacy in steroid-resistant population
-- A short course treatment that can prevent further exacerbations of COPD
About Mereo
Mereo is a biopharmaceutical company focused on the development
and commercialisation 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. 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,
randomised, 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
Q2 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 a Phase 2 dose ranging
study in the US with data expected in late 2019;
-- BCT-197 (acumapimod) for acute exacerbations of COPD
(AECOPD). The Company announced positive Phase 2 data in May 2018;
and
-- BGS-649 for hypogonadotropic hypogonadism (HH). The Company
announced positive top-line Phase 2b data in March 2018 and
positive results from the Phase 2b safety extension study in
December 2018.
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
Jill Steier
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END
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