4d Pharma PLC 4D Presents Phase Ib Clinical Data on Thetanix®
16 Maggio 2019 - 08:01AM
RNS Non-Regulatory
TIDMDDDD
4d Pharma PLC
16 May 2019
4D pharma plc
(the "Company" or "4D")
4D Presents Phase Ib Clinical Data on Thetanix(R)
4D pharma plc (AIM: DDDD), a pharmaceutical company focusing on
the development of Live Biotherapeutics, today announced that data
from the completed Phase Ib clinical study of Thetanix(R) for the
treatment of Crohn's disease will be presented on 18 May in a
poster session at the 2019 Digestive Disease Week meeting in San
Diego. The poster was nominated as a "Poster of Distinction" within
the top 10% of posters submitted to the congress. The Company has
previously announced the top-line results from this study.
The randomised, double-blind, placebo-controlled study was
conducted in two parts, with a single-dose phase and a
multiple-dose phase and treated a total of 18 adolescent patients
with Crohn's disease. In the single-dose phase, eight subjects were
given a single dose of either Thetanix(R) or placebo. In the
multiple-dose phase, 10 subjects were given either Thetanix(R) or
placebo twice daily for seven consecutive days.
This study met its primary objective, demonstrating that
Thetanix(R) was well tolerated with a good safety profile.
The Lead Investigator Richard Hansen, Consultant Paediatric
Gastroenterologist, Royal Hospital for Children, Glasgow will also
give an oral presentation on this data at the 52(nd) Annual Meeting
of the European Society for Paediatric Gastroenterology, Hepatology
and Nutrition (ESPGHAN) in Glasgow, UK, on 7 June 2019.
The poster and presentation from these meetings will be made
available on the 4D website in due course.
For further information please contact:
4D
Duncan Peyton, Chief Executive Officer + 44 (0)113 895 0130
Fay Weston, Head of Investor Relations + 44 (0)7990 381713
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 bacterium, that is applicable to the
prevention, treatment or cure of a disease. 4D has developed a
proprietary platform, MicroRx(R) , that rationally identifies novel
bacteria 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. 4D has three clinical studies in progress, namely a Phase II
clinical study of Blautix(R) in Irritable Bowel Syndrome, a Phase
I/II study of MRx0518 in combination with Keytruda(R) in solid
tumours and a Phase I study of MRx0518 in a neoadjuvant setting for
patients with solid tumours. Other focus programmes include disease
areas such as asthma and CNS disease.
About Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disease which
can occur in any part of the gastro-intestinal tract, but primarily
affects the small intestine. Patients suffer from diarrhoea, rectal
bleeding and abdominal pain. Many often require long-term medical
therapy, are repeatedly hospitalised and may even require surgical
intervention. Crohn's disease remains an area of significant unmet
medical need. In the mild-to-moderate population, patients are
typically treated with long-term immunosuppressants, which are not
effective in all individuals and often lead to the development of
severe side effects. Safe and effective novel drugs are needed to
provide improved treatment options for patients, particularly in
the maintenance therapy setting. The global market for Crohn's
disease was worth $10.4 billion in 2017 and is expected to grow to
approximately $11.5 billion by 2024.
Paediatric CD is a severe condition with additional health
impacts such as impaired development and growth retardation. The
frequency of extensive disease with more severe lower bowel
involvement is much more common in the paediatric population than
in adults. Immunomodulators, biologics and steroids, whilst used
widely to treat the adult population are often considered too
aggressive for use in children and there is a clear unmet need for
safe and effective long-term alternatives to these products.
About Thetanix(R)
Thetanix(R) is a single-strain Live Biotherapeutic candidate in
development for the treatment of Crohn's disease. It acts upstream
of many biologics that are approved for Crohn's disease and
inhibits NF-<KAPPA>B activation which has been found to be
overactive in many inflammatory diseases. A pirin-like protein
(PLP) produced by the bacteria has been identified as a candidate
effector molecule. In addition to showing efficacy in multiple
preclinical models of Inflammatory Bowel Disease, the Phase Ib
study demonstrated safety and tolerability and a Phase II study is
being planned. Thetanix(R) has orphan drug designation for
paediatric Crohn's disease.
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