TIDMDDDD
RNS Number : 1146K
4d Pharma PLC
20 April 2020
4D pharma plc
(the "Company" or "4D")
Expedited UK regulatory acceptance to commence Phase II study in
COVID-19
LEEDS, UK -- 4D pharma plc (AIM: DDDD), a pharmaceutical company
leading the development of Live Biotherapeutics (LBP), today
announces that the Company has received expedited acceptance from
the UK Medicines and Healthcare products Regulatory Agency (MHRA)
to commence a Phase II study of MRx-4DP0004 in patients with
COVID-19.
COVID-19
COVID-19, caused by infection with SARS-CoV-2, has emerged as a
significant global threat and is placing a huge burden on
healthcare systems worldwide. Although many patients exhibit only
mild symptoms, approximately 15-20% develop severe disease
requiring hospitalisation and oxygen support. Approximately 5% of
all patients require admission to an intensive care unit (ICU).
Accumulating evidence suggests that the high mortality rate of
COVID-19 may be due to the hyper-inflammatory response and cytokine
storm syndrome caused by uncontrolled activation of the immune
system and targeted immunomodulation may be beneficial in these
patients(1) .
There is an urgent need for a safe and effective therapy to
prevent and treat the severe inflammatory symptoms of COVID-19, and
to alleviate the significant burden on ICUs in hospitals
worldwide.
MRx-4DP0004
MRx-4DP0004 is an orally administered, single-strain Live
Biotherapeutic currently in a Phase I/II clinical trial for the
treatment of patients with partly-controlled asthma. To date, 20
patients have been dosed, with no drug related serious adverse
events. In preclinical studies the Company has previously shown
that MRx-4DP0004 is able to significantly reduce lung inflammation
and impact particular immune cell types and pathways which have
more recently been implicated in the hyperinflammatory response to
SARS-CoV-2 infection.
In a preclinical model of severe asthma, MRx-4DP0004
significantly reduced airway inflammation, including a reduction in
the number of neutrophils, eosinophils and activated dendritic
cells. The LBP candidate also reduced pro-inflammatory cytokines in
lung tissues(2) . The systemic immunomodulatory effects of
MRx-4DP0004 have also been demonstrated in additional preclinical
models of inflammatory diseases including multiple sclerosis and
rheumatoid arthritis.
Study Design
The randomised, double-blind, placebo-controlled Phase II study
will evaluate the efficacy and safety of MRx-4DP0004, in addition
to standard-of-care in up to 90 patients hospitalised with symptoms
indicative of COVID-19. Eligible participants will be randomised
2:1 to receive 14 days of treatment with either MRx-4DP0004 or
placebo (two capsules twice daily). Participants will be monitored
daily throughout the treatment period for improvement or
progression of COVID-19 symptoms and adverse events. Following
completion of the treatment period, participants will be
followed-up at approximately 14 and 28 days post treatment.
Patients will be recruited at sites across the UK.
The primary endpoint will be the mean change in clinical status
score as measured by the WHO Ordinal Scale for Clinical
Improvement. Secondary endpoints include safety and tolerability as
well as a suite of additional measures of clinical efficacy
including the need for and duration of ventilation. Further
information will be made available at clinicaltrials.gov in due
course.
4D's Chief Scientific Officer, Alex Stevenson, commented:
"Over the last month we have worked intensively with our
clinical collaborators and the regulatory agencies to accelerate
the assessment of MRx-4DP0004 in COVID-19 patients. C learly this
is a fast moving and rapidly developing situation. As an integrated
company we have manufacturing capability to provide drug and our
key focus over the coming weeks will be initiating the trial as
soon as possible. If MRx-4DP0004 is successful in this study it
would represent a highly significant breakthrough in the global
fight against the novel coronavirus pandemic."
The study's Lead Investigator, Dr. Dinesh Saralaya (Consultant
Respiratory Physician and Associate Director of Research at
Bradford Teaching Hospitals NHS Foundation Trust, and the National
Institute for Health Research's (NIHR) Clinical Lead for
Respiratory industry studies), commented:
"The COVID-19 pandemic presents an unprecedented challenge to
our healthcare systems and we desperately require the rapid
development of new therapies to ease the burden on our intensive
care units. Given the scale and urgency of the situation it is
vitally important that we generate evidence to support the use of
new candidates as quickly as possible, before these can be rolled
out to patients who need them."
He added: "As well as its appropriate mechanism of action, the
highly favourable safety profile of MRx-4DP0004 makes it a
particularly attractive candidate for COVID-19 patients, and may
potentially allow us to prevent or delay their progression to
requiring ventilation and intensive care."
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 five 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 and a
Phase I/II study of MRx-4DP0004 in asthma. Preclinical-stage
programmes 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 .
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 and EU, 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.
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 / Alex Bond (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
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
(1) Mehta, Puja et al., COVID-19: consider cytokine storm
syndromes and immunosuppression, The Lancet, Volume 395, Issue
10229, 1033 - 1034
(2) Raftis et al. Bifidobacterium breve MRx0004 protects against
airway inflammation in a severe asthma model by suppressing both
neutrophil and eosinophil lung infiltration. Sci Rep 8, 12024
(2018).
This announcement contains inside information as defined in
Article 7 of the Market Abuse Regulation No. 596/2014 ("MAR"). The
person responsible for making this announcement for the Company is
Duncan Peyton. Upon the publication of this announcement, this
inside information is now considered to be in the public
domain.
This information is provided by RNS, the news service of the
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END
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