LEEDS, England, July 8, 2019 /PRNewswire/ -- 4D pharma plc (AIM:
DDDD), a pharmaceutical company leading the development of Live
Biotherapeutics, today announces an update on its lead Live
Biotherapeutic candidate for asthma, MRx-4DP0004.
A multicentre Phase I/II double-blind, placebo-controlled study
of MRx-4DP0004 in patients with poorly controlled asthma has now
commenced. The study will enrol 90 asthma patients not adequately
controlled on their current inhaler maintenance therapy. Patients
will take MRx-4DP0004 in addition to existing maintenance therapy.
This is the world's first clinical study of a Live Biotherapeutic
in patients with poorly controlled asthma. It is anticipated that
the results of this study will be available in 2020.
The primary endpoints of this study are safety and tolerability
of MRx-4DP0004 when added to long-term maintenance therapy, with
secondary endpoints including reduction of asthma symptoms,
exacerbations, hospitalisations and the achievement of improved
asthma control. The principal investigator for this study is Prof.
Chris Brightling, University of
Leicester.
This study builds on 4D's published data (Raftis et al.,
Scientific Reports 2018) demonstrating that MRx-4DP0004 can
significantly reduce both neutrophil and eosinophil airway
infiltration concurrently and outperformed standard therapeutics in
a preclinical disease model of severe steroid-resistant asthma.
Alex Stevenson, 4D's Chief
Scientific Officer, commented: "Commencing this study further
underlines 4D's commitment to unlocking the full potential of the
gut microbiome and Live Biotherapeutics or 'LBPs' to treat diseases
beyond the gastrointestinal tract. This year, we have expanded our
clinical pipeline to evaluate LBPs in diseases anatomically distant
from the gut, firstly in oncology, and now in asthma."
He added, "Despite available therapies, many asthma patients
struggle to achieve control of their disease and suffer from
exacerbations often requiring hospitalisation. The results from
this study will be an important proof-of-concept in the development
of live biotherapeutics as a next generation therapy in asthma
management."
About 4D
Founded in February 2014, 4D is a
world leader in the development of Live Biotherapeutics, a novel
and emerging class of drugs, defined by the FDA as biological
products that contain a live organism, such as a bacterium, that is
applicable to the prevention, treatment or cure of a disease. 4D
has developed a proprietary platform that rationally identifies
novel bacteria based on a deep understanding of function and
mechanism. 4D's Live Biotherapeutic products are orally delivered
single strains of bacteria that are naturally found in the healthy
human gut. 4D has four clinical studies in progress, namely a
Phase II clinical study of Blautix in Irritable Bowel Syndrome, a
Phase I/II study of MRx0518 in combination with
KEYTRUDA® (pembrolizumab) in solid
tumours, a Phase I study of MRx0518 in a neoadjuvant setting for
patients with solid tumours and a Phase I/II study of MRx4DP0004 in
asthma. Other focus programmes include disease areas such as CNS
disease.
About Asthma
Asthma is an inflammatory disease of the lungs characterized by
recurring symptoms, reversible airflow obstruction, and
bronchospasm. Between 5-10% of asthma patients have the severe form
of the disease, which is refractory to steroid treatment and cannot
be controlled with high-intensity treatments and accounts for more
than 50% of asthma associated healthcare costs. There is a growing
body of evidence linking the gut microbiome to the development of
asthma. The asthma therapeutics market is projected to reach to
$23.1 billion by 2023
In severe asthma, airway inflammation can be predominantly
eosinophilic, neutrophilic or mixed. Whilst a number of biologics
have recently been approved to treat patients with eosinophilic
disease, there are currently no approved therapies for patients who
present with a neutrophilic phenotype.
About MRx4DP0004
MRx4DP0004 has demonstrated strong and significant efficacy in
industry standard preclinical models of steroid-resistant severe
asthma. It was shown to reduce both neutrophils and eosinophils in
both prophylactic and therapeutic settings. The efficacy was also
reflected in a reduction in histopathological lung inflammation,
and specific subsets of T cells and dendritic cells.
Notably, MRx4DP0004 outperformed the anti-IL-17 positive control
in this model and was able to reduce airway neutrophils and
eosinophils concurrently, which is not achievable with existing
therapeutics. In addition to standard maintenance therapy such as
inhaled corticosteroids (ICS) and long acting beta agonists (LABA),
MRxDP0004 may provide benefits to patients with only partly
controlled asthma.
For more information about the clinical study please visit
https://clinicaltrials.gov/ct2/show/NCT03851250
For more information, refer to https://www.4dpharmaplc.com/
For further information please contact:
4D
Duncan Peyton,
Chief Executive Officer, +44(0)113-895-0130
Fay Weston, Head of Investor
Relations, +44(0)7990-381713
N+1 Singer - Nominated Adviser and Joint Broker,
+44(0)20-7496-3000
Aubrey Powell/ Justin McKeegan/ Alex
Bond (Corporate Finance)
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co.
Limited - Joint Broker, +44(0)20-7332-2500
Dominic Wilson / Phil Walker
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SOURCE 4D pharma plc