4d Pharma PLC Clinical Update (5352Y)
06 March 2017 - 6:00PM
UK Regulatory
TIDMDDDD
RNS Number : 5352Y
4d Pharma PLC
06 March 2017
This announcement contains inside information
4D pharma plc
(the "Company" or "4D")
Clinical Update
4D pharma plc (AIM: DDDD), a pharmaceutical company focusing on
the development of live biotherapeutics, today provides the
following update on the development and first clinical trial of its
proprietary diagnostic platform, MicroDx.
MicroDx has been designed to diagnose, stratify and monitor the
treatment of patients based on their gut microbiome, the bacteria
which colonise the human gastro-intestinal tract. 4D has developed
a strategy to identify bacteria in the gut to allow for diagnosis
of disease which, when combined with the therapeutics developed by
4D, may provide for efficient and effective options for clinicians,
patients and payers.
Importantly, MicroDx is able to identify 'signatures' based on
the functionality of the gut microbiome, and also on metabolite
profiles (small molecules produced by the microbiome). This advance
by 4D will allow the development of rapid methods of diagnosis,
that could be readily transferred into the clinical setting.
Running concurrently with the development of Blautix, 4D's first
live biotherapeutic development programme, the first clinical trial
of MicroDx is being carried out in Irritable Bowel Syndrome (IBS).
IBS is a functional bowel disorder characterised by discomfort,
pain and changes in bowel habits, affecting 10-15% of the
population. It is subdivided into constipation (C), diarrhoea (D)
and mixed (M) subtypes. All subtypes are represented in the 80 IBS
subjects in the MicroDx trial.
Interim analysis of data generated in the MicroDx clinical study
has revealed the following:
-- There are significant differences between the microbiota
profiles of IBS patients and healthy subjects
-- The microbiota of IBS clinical subtypes are not significantly
different, supporting the rationale for Blautix as a therapy for
all IBS subtypes
-- MicroDx is able to differentiate IBS patients from healthy
subjects based on metabolite profiles.
Duncan Peyton, 4D's Chief Executive Officer, commented:
"Companion diagnostics have long been associated with helping to
provide more accurate and effective treatment outcomes. Advances in
the understanding of the interaction of our microbiome and disease
are leading not only to new discoveries and possibilities in
therapeutics, as we have shown with our MicroRx platform, but also
in how we diagnose and treat disease. The early clinical results
from our MicroDx platform are very promising. The exceptional
efforts of our team have potentially opened the way for a point of
care diagnostic for IBS, and provided the means to monitor our
therapeutic intervention Blautix, our clinical stage programme for
the treatment of IBS. Moving forward, we will be incorporating
MicroDx into our upcoming live biotherapeutic clinical studies in
cancer and severe asthma, planned for later this year."
For further information please contact:
4D + 44 (0)113 895 0130
Duncan Peyton, Chief Executive Officer
Zeus Capital Limited - Nomad and Broker
Dan Bate +44 (0) 161 831 1512
Dominic Wilson +44 (0) 203 829 5000
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 bacteria, that is applicable to the
prevention, treatment or cure of a disease. 4D has developed a
proprietary platform, MicroRx, that rationally identifies novel
bacteria that have a precise and evolved therapeutic effect. All of
4D's live biotherapeutic products are orally delivered single
strains of bacteria that are naturally found in the healthy human
gut. 4D currently has a pipeline of 13 preclinical programmes,
covering disease areas such as rheumatoid arthritis, multiple
sclerosis and cancer, and is currently conducting subject trials in
Irritable Bowel Syndrome and Paediatric Crohn's Disease. The
programmes in Paediatric Ulcerative Colitis and Paediatric Crohn's
Disease have both been granted Orphan Drug Status by the FDA.
About IBS
IBS is a functional bowel disorder characterised by discomfort,
pain and changes in bowel habits. Symptoms can be mild, moderate or
severe. Mild symptoms, which occur infrequently, can sometimes
interfere with normal daily functioning. Moderate symptoms are more
intense, occur more frequently, and often interfere with daily
functioning. Severe symptoms chronically interfere with daily
functioning. It is estimated that 10-15% of the population have
IBS, with only 30-35% of subjects seeking medical attention, the
majority of which have persistent symptoms. There are currently few
approved treatment options, all of which focus on the modulation of
symptoms.
This information is provided by RNS
The company news service from the London Stock Exchange
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