TIDMMPH
RNS Number : 2715G
Mereo BioPharma Group plc
05 November 2018
Mereo BioPharma Group plc
("Mereo" or the "Company")
First patient dosed in Phase 2 Alpha-1 Antitrypsin Deficiency
Study
Investment from The Alpha-1 Project
Top line data expected H2 2019
London, 5 November 2018 - Mereo BioPharma Group plc (AIM: MPH),
a clinical stage UK based biopharmaceutical company focused on rare
diseases, is pleased to announce that the first patient has been
dosed in its Phase 2 clinical study of MPH-966 (alvelestat) for the
treatment of alpha-1 antitrypsin deficiency (AATD). The study is
being conducted in the United States and Europe with top line data
expected in H2 2019.
The Company also announced today a collaboration with and
investment from the venture philanthropy arm of the Alpha-1
Foundation, The Alpha-1 Project, Inc. (TAP). TAP is investing in
Mereo's MPH-966 development programme subject to the Company
meeting agreed development milestones. The Company has also agreed
to issue warrants to TAP, on future dates, to subscribe for shares
in the Company subject to TAP making the agreed investments in the
programme with the first such investment milestone being the dosing
of the first patient in the MPH-966 development programme.
AATD is a potentially life-threatening rare, genetic condition,
with an estimated 50,000 patients in North America and 60,000
patients in Europe suffering from a severe form of the disease. It
can cause severe debilitating conditions such as chronic liver
disease but, most notably, pulmonary emphysema, which is a
life-threatening disease. Current standard of care for AATD often
involves protein replacement therapy, which requires weekly
intravenous infusions of plasma-derived alpha 1 antitrypsin,
however, fewer than 10,000 patients are currently treated with this
therapy in the U.S. and it is not currently available in some
European countries. MPH-966 is an oral neutrophil elastase
inhibitor that specifically targets the neutrophil elastase which
is primarily responsible for the lung degradation in AATD patients.
Mereo therefore believes MPH-966 is highly differentiated from
protein replacement therapy.
The Phase 2 study is a 12-week randomized, placebo controlled,
clinical trial evaluating two doses of MPH-966 in approximately 165
patients with the PiZZ or NULL genetic mutations. These mutations
are associated with the more severely affected patients who have
very low (PiZZ) or zero (NULL) alpha-1 antitrypsin levels. The
primary endpoint of the study is the change from baseline on
biomarkers of neutrophil activity through the measurement of
desmosine/isodesomine at 12 weeks compared to placebo. Desmosine
has been shown to correlate with deterioration of lung tissue as
determined by CT scans in previous studies in AATD patients. If the
results of this trial are positive, Mereo intends to seek
regulatory advice on the design of a pivotal trial.
Jean-Marc Quach, President and CEO of The Alpha-1 Project
said:
"We are very pleased that the first patient has been
successfully dosed in this phase 2 study in alpha-1 antitrypsin
deficiency. We are excited by the potential for a new oral
therapeutic to improve the lives of our patients with this
debilitating disease and are pleased to be supporting Mereo with
this phase 2 study."
Dr Denise Scots-Knight, Chief Executive Officer of Mereo
BioPharma Group plc commented:
"We are happy to announce today, both that the first patient has
been dosed in this clinical study and that we have agreed an
investment from the Alpha-1 Foundation through TAP. We strive to
work closely with patient groups who support those with the orphan
and rare diseases we are targeting and are delighted to be working
with the Foundation on this study. We will continue to enrol
patients over the coming months and look forward to reporting top
line data in the second half of 2019."
For further information on patient recruitment of this trial,
visit: https://clinicaltrials.gov/ NCT identifier: 03636347
About Mereo BioPharma
Mereo is a biopharmaceutical company focused on the development
and commercialization of innovative therapeutics that aim to
improve outcomes for patients with rare diseases. The portfolio
currently consists of four clinical-stage product candidates, each
of which were acquired from large pharmaceutical companies: BPS-804
(setrusumab) for the treatment of osteogenesis imperfecta ("OI");
MPH-966 (alvelestat) for the treatment of severe alpha-1
antitrypsin deficiency ("AATD"); BCT-197 for the treatment of acute
exacerbations of chronic obstructive pulmonary disease, ("AECOPD");
and BGS-649 for the treatment of hypogonadotropic hypogonadism
("HH") in obese men. Each of the Company's product candidates has
generated positive clinical data for Mereo's target indication or
in a related indication. 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 manufacturing data packages. Since
inception the Company has commenced large, randomized,
placebo-controlled Phase 2 clinical trials for all four of the
product candidates and has previously announced positive top-line
results from two of its clinical trials: a Phase 2 trial with
BCT-197 in December 2017 and a Phase 2b dose-ranging study with
BGS-649 in March 2018. The company also recently announced
completion of enrolment with [112] patients in the Phase 2b dose
ranging study of BPS-804 in osteogenesis imperfecta with [112]
adult patients.
About The Alpha-1 Project
Mission statement: The Alpha-1 Project works with patients,
academia, pharmaceutical and biotech companies, and public health
organizations in the relentless pursuit of cures and therapies for
COPD and liver disease caused by Alpha-1 Antitrypsin Deficiency.
For more information, visit www.thealpha-1project.com. The Alpha-1
Project is a wholly-owned for-profit subsidiary of the Alpha-1
Foundation. For more information on the Foundation, visit
www.alpha1.org.
About AATD
AATD is a genetic disorder that affects approximately 100,000
patients in the United States and 120,000 patients in Europe
rarediseases.org/rare-diseases/alpha-1-antitrypsin-deficiency. The
severe population represents approximately 50,000 patients in North
America and 60,000 patients in Europe. It can cause severe
debilitating conditions such as chronic liver disease but, most
notably, pulmonary emphysema, which is a life-threatening disease.
Pulmonary emphysema results in irreversible destruction of the
tissues supporting the function of the lungs and causing severe
shortness of breath and wheeze. Patients typically present between
the ages of 20 and 50 and have both a significantly reduced quality
of life and a reduced life expectancy.
The lung damage in AATD results from loss of the normal
protective effect of alpha-1 antitrypsin against the damaging
enzymes released during inflammation, specifically neutrophil
elastase.
Current standard of care for AATD varies from country to
country. Protein replacement therapy, involving weekly infusions of
plasma-derived alpha 1 antitrypsin is approved but only approx.
9,000 patients are treated in the US. By suppressing neutrophil
elastase through a more easily administered oral treatment, Mereo
believes MPH966 has significant differentiation from the current
protein replacement therapy.
AstraZeneca has conducted a number of Phase I and Phase II
clinical studies with MPH966 in respiratory conditions that share
some common pathology with AATD, specifically chronic obstructive
pulmonary disease ("COPD"), cystic fibrosis and bronchiectasis.
Approximately 1,000 patients have been treated with the drug in
clinical studies to date. These studies have shown MPH966 to be
safe and well-tolerated. They have also generated signals of
efficacy in lung function and biomarker data that are consistent
with an elastase-mediated mechanism of action.
Enquiries:
Mereo BioPharma Group plc +44 (0)333 023 7300
Denise Scots-Knight, Chief Executive
Officer
Richard Jones, Chief Financial Officer
Cantor Fitzgerald Europe (Nominated
Adviser and Broker) +44 (0)20 7894 7000
Phil Davies
Will Goode
Rick Thompson
RBC Capital Markets (Joint Broker) +44 (0)20 7653 4000
Rupert Walford
Jamil Miah
FTI Consulting (Public Relations Adviser) +44 (0)20 3727 1000
Simon Conway
Brett Pollard
Burns McClellan (US Public Relations
Advisor to Mereo Biopharma) +01 (0) 212 213 0006
Lisa Burns
Ami Bavishi
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END
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