4d Pharma PLC Clinical Update (6323R)
13 December 2016 - 6:00PM
UK Regulatory
TIDMDDDD
RNS Number : 6323R
4d Pharma PLC
13 December 2016
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 phase 1 clinical trial in respect of
Blautix, its proprietary single strain live biotherapeutic for the
treatment of 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. Alteration of the microbiome of IBS patients is a
recognised feature of the disease, and many patients have a
microbiome that is more unstable and less diverse than that of
healthy individuals.
Blautix is the Company's first orally delivered, single strain
live biotherapeutic to undergo a clinical trial. As previously
reported, the primary objective of the study was met, demonstrating
that Blautix was safe and well tolerated. Furthermore, the Company
reported trends indicating that IBS subjects receiving Blautix
showed greater levels of symptom relief than those receiving
placebo. The Company has now completed further analysis of patient
samples, showing the positive impact of Blautix on the stability
and diversity of the microbiome.
Throughout the trial, analysis of both healthy volunteer and IBS
patient microbiomes was performed prior to dosing, after dosing and
following a washout period. The analysis looked at both the
stability and diversity of the microbiome, both of which are
typically reduced in IBS patients compared to healthy volunteers.
IBS patients receiving Blautix showed an increase in microbiome
diversity and microbiome stability that was comparable to healthy
controls. Conversely, as expected, IBS patients receiving placebo
showed a reduction in microbiome diversity and exhibited microbiome
instability over the period of the trial. This result may be
indicative of a relevant therapeutic effect of Blautix and will be
investigated further in phase II clinical studies scheduled for
2017.
Dr. Alex Stevenson, 4D's Chief Scientific Officer, commented:
"Reduction in the stability and diversity of the microbiome is a
recognised aspect of IBS pathophysiology. These results demonstrate
that Blautix, our single strain live biotherapeutic for the
treatment of IBS, is able to increase the stability and diversity
of the microbiome in IBS patients. In addition to the previously
reported results, this finding is very encouraging for the future
clinical development of Blautix and our other single strain live
biotherapeutic products."
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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