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4d Pharma PLC
02 July 2020
4D pharma plc
(the "Company" or "4D")
Phase II study of MRx-4DP0004 in patients hospitalized with
COVID-19 open for enrolment
Dosing of first patients expected to commence shortly
Leeds, UK, 2 July, 2020 - 4D pharma plc (AIM: DDDD), a
pharmaceutical company leading the development of Live
Biotherapeutics, today announces that its Phase II clinical trial
of oral immunomodulator MRx-4DP0004 for patients hospitalised with
COVID-19 is now open to enrolment, and dosing of the first patients
is expected shortly.
The Phase II randomized, double-blind, placebo-controlled trial
is enrolling up to 90 patients admitted to hospital with COVID-19
in the UK. Eligible patients will receive daily oral MRx-4DP0004 or
placebo, in addition to standard supportive care. The primary
endpoint of the trial is the mean change in clinical status score
as measured by the WHO Ordinal Scale for Clinical Improvement. In
addition, a number of secondary endpoints assess measures of
clinical efficacy including the need for, and duration of,
ventilation, in addition to safety and tolerability.
4D pharma's Live Biotherapeutic MRx-4DP0004 has shown the
potential to simultaneously down-regulate specific pathological
aspects of the hyper-inflammatory response to viral infection,
while maintaining the appropriate anti-viral response. Both are key
factors in the effective treatment of the respiratory symptoms
associated with COVID-19, not only for hospitalised patients with
more severe disease but potentially also in patients with milder
symptoms to prevent disease progression and hospitalisation.
As a Live Biotherapeutic, MRx-4DP0004 is expected to display a
favourable safety profile. In an ongoing asthma study MRx-4DP0004
has demonstrated an excellent safety profile to date. Particularly
in the context of the COVID-19 crisis, the safety of this Live
Biotherapeutic is critical, in contrast to the known side-effect
profiles of other therapies in clinical trials for COVID-19.
Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma
commented, "Reducing hyperinflammation, particularly in the lungs,
is key to preventing the exacerbation of symptoms associated with
more severe COVID-19. 4D pharma has shown MRx-4DP0004 has the
ability to target inflammation in the lungs, potentially reducing
the respiratory issues central to COVID-19. 4D pharma aims to use
this study to generate robust, meaningful clinical data that will
support a safe immunomodulatory Live Biotherapeutic intervention
for patients hospitalised with COVID-19."
He added, "Immunomodulatory intervention in COVID-19 is
supported by recent positive results from the UK's RECOVERY trial,
showing dexamethasone reduces the risk of death in hospitalised
patients. We believe MRx-4DP0004 has a mechanism of action that may
be complementary to that of dexamethasone, which has now become
standard-of-care across the UK's National Health Service (NHS).
Importantly, in our ongoing asthma study the addition of
MRx-4DP0004 to glucocorticoid treatments (the same class of
medicines as dexamethasone) has to date been safe and well
tolerated, positioning MRx-4DP0004 to be able to progress rapidly
in this new standard-of-care setting. 4D pharma intends to develop
MRx-4DP0004 to prevent hospitalised COVID-19 patients deteriorating
to the point of needing invasive ventilation and intensive care,
and thus alleviate the greatest burdens facing healthcare services.
Following positive data from the COVID-19 clinical trial, 4D pharma
intends to explore the potential utility of MRx-4DP0004 in
additional viral infections like influenza."
About MRx-4DP0004
MRx-4DP0004 is a single-strain Live Biotherapeutic in
development for the treatment of asthma and COVID-19. It has
demonstrated strong and significant efficacy in industry standard
preclinical models of steroid-resistant severe asthma. MRx-4DP0004
was shown to reduce both neutrophils and eosinophils in
prophylactic and therapeutic settings in vivo. The efficacy was
also reflected in a reduction in histopathological lung
inflammation, and specific subsets of T cells, dendritic cells and
inflammatory cytokines.
4D is currently investigating MRx-4DP0004 in a Phase I/II study
in patients with partly-controlled asthma. The study, taking place
at sites across the UK, is evaluating the safety and preliminary
clinical efficacy of MRx-4DP0004 in addition to standard
maintenance therapy such as inhaled corticosteroids (ICS) and long
acting beta agonists (LABA), in up to 90 patients. For more
information about the clinical study please visit
https://clinicaltrials.gov/ct2/show/NCT03851250 .
The Company has received expedited acceptance from the MHRA to
conduct a Phase II study of MRx-4DP0004 in up to 90 patients
hospitalised with suspected or confirmed COVID-19. For more
information about the clinical study please visit
https://clinicaltrials.gov/ct2/show/NCT04363372 .
About 4D
Founded in February 2014, 4D pharma 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, MicroRx(R), that rationally identifies Live
Biotherapeutics 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. The Company has six clinical studies in progress, namely a
Phase II clinical study of BLAUTIX(R) in Irritable Bowel Syndrome
(IBS), a Phase I/II study of MRx0518 in combination with
KEYTRUDA(R) (pembrolizumab) in solid tumours, a Phase I study of
MRx0518 in a neoadjuvant setting for patients with solid tumours, a
Phase I study of MRx0518 in patients with pancreatic cancer, a
Phase I/II study of MRx-4DP0004 in asthma, and a Phase II study of
MRx-4DP0004 in patients hospitalised with COVID-19.
Preclinical-stage programs include candidates for CNS disease such
as Parkinson's disease and other neurodegenerative conditions. The
Company has a research collaboration with MSD, a tradename of Merck
& Co., Inc., Kenilworth, NJ, USA, to discover and develop Live
Biotherapeutics for vaccines.
For more information, refer to https://www.4dpharmaplc.com .
Contact Information:
4D
Duncan Peyton, Chief Executive Officer +44 (0)113 895 0130
Investor Relations ir@4dpharmaplc.com
N+1 Singer - Nominated Adviser and Joint Broker +44 (0)20 7496 3000
Aubrey Powell / Justin McKeegan / Iqra Amin (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332 2500
Dominic Wilson / Phil Walker
Image Box PR
Neil Hunter / Michelle Boxall +44 (0)20 8943 4685
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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