4d Pharma PLC MHRA and HPRA clear Blautix Phase II study
June 13 2018 - 1:01AM
RNS Non-Regulatory
TIDMDDDD
4d Pharma PLC
13 June 2018
4D pharma plc
(the "Company" or "4D")
MHRA and HPRA clear Blautix Phase II study
4D pharma plc (AIM: DDDD), a pharmaceutical company leading the
development of live biotherapeutics, today announced that the
Company has received clearance from the Medicines and Healthcare
Products Regulatory Agency (MHRA) and the Health Products
Regulatory Authority (HPRA) to commence the Phase II study of
Blautix, the Company's live biotherapeutic for the treatment of
Irritable Bowel Syndrome (IBS), at sites in the UK and Ireland.
This follows an announcement made by the Company in May that the
US Food and Drug Administration (FDA) had cleared the Company's
Investigational New Drug application to commence the Phase II study
at sites in the US. Enrolment in the study is expected to commence
in the second half of 2018.
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 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 welcome this development which illustrates the international
breadth of the study, set to take place at more than 10 sites
across the US, UK and Ireland. This will be the largest live
biotherapeutic clinical trial conducted to date and reflects our
commitment to generate robust clinical data in large,
well-controlled studies, which are aligned with the expectations of
the regulatory authorities. We look forward to commencing enrolment
of this study shortly."
For further information please contact:
4D + 44 (0)113 895 0130
Duncan Peyton, Chief Executive Officer
Zeus Capital Limited - Nomad and Joint Broker
Dan Bate / Jordan Warburton +44 (0) 161 831 1512
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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END
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