4d Pharma PLC Clinical Update - Blautix Phase II study (6934G)
November 08 2018 - 2:00AM
UK Regulatory
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RNS Number : 6934G
4d Pharma PLC
08 November 2018
4D pharma plc
(the "Company" or "4D")
Clinical Update - Blautix Phase II study
4D pharma plc announces first patient enrolment in Blautix IBS
Phase II study
4D pharma plc (AIM: DDDD), a pharmaceutical company leading the
development of Live Biotherapeutics, is pleased to announce the
randomisation of the first patient in a Phase II clinical trial of
Blautix in patients with Irritable Bowel Syndrome (IBS). The study
will recruit up to 500 patients at sites across the US and EU and
is set to be the largest clinical trial of a Live Biotherapeutic
conducted to date.
The double-blind, placebo-controlled multicentre Phase II study
will evaluate the efficacy and safety of Blautix in patients with
IBS with constipation (IBS-C) and/or IBS with diarrhoea (IBS-D).
The Company has consulted with the FDA on the design of the study.
Up to 500 patients will receive either Blautix or placebo daily for
8 weeks. The primary endpoint will be the Overall Response rate,
defined as the proportion of patients reporting an improvement in
their weekly cohort-specific symptoms (abdominal pain and stool
frequency or consistency) for at least 4 out of 8 weeks. A range of
secondary efficacy endpoints will also be assessed, as well as the
effects of Blautix on the gut microbiome.
Dr. Alex Stevenson, 4D's Chief Scientific Officer, commented:
"We are delighted to have enrolled the first patient in this
important study, which brings us another step towards making
Blautix available for patients. IBS remains an area of significant
unmet need, with existing treatments limited to symptom management
and many patients struggling to achieve relief. By targeting the
gut microbiome, Blautix targets the underlying pathophysiology of
IBS and has the potential to fundamentally change the way these
patients are treated."
For further information please contact:
4D + 44 (0)113 895 0130
Duncan Peyton, Chief Executive Officer
Zeus Capital Limited - Nomad and Joint Broker +44 (0) 161 831 1512
Dan Bate / Jordan Warburton
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332 2500
Dominic Wilson / Phil Walker
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 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 has
completed a Phase I study in Irritable Bowel Syndrome and has
completed dosing in a Phase I study in Paediatric Crohn's Disease.
It currently has a pipeline of 13 pre-clinical programmes, covering
disease areas such as cancer, poorly controlled asthma, autoimmune
and CNS disease, and plans to commence four additional clinical
studies in 2018.
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.
About Blautix
Blautix is a single-strain Live Biotherapeutic candidate in
development for the treatment of IBS with constipation (IBS-C) and
IBS with diarrhoea (IBS-D). The organism was originally isolated
from a healthy individual and has a distinctive metabolism which
utilises intestinal hydrogen as an energy source, reduces levels of
hydrogen sulphide, and increases microbiota diversity and
stability. Unlike existing therapies which only seek to address IBS
symptoms, by targeting the microbiome Blautix has the potential to
act directly on the underlying pathophysiology of disease to treat
all IBS patients irrespective of traditional sub-types.
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