4d Pharma PLC Clinical update and publication of studies (6071B)
September 24 2018 - 1:00AM
UK Regulatory
TIDMDDDD
RNS Number : 6071B
4d Pharma PLC
24 September 2018
4D pharma plc
(the "Company" or "4D")
Thetanix - clinical update and publication of studies
4D announces positive data from Phase Ib study of Thetanix in
paediatric Crohn's disease patients and publication of studies
showing strong efficacy of Thetanix in preclinical models of
IBD
24 September 2018 - 4D pharma plc (AIM: DDDD), a pharmaceutical
company leading the development of live biotherapeutics, today
announces positive top-line results for its Phase Ib study of
Thetanix in paediatric patients with Crohn's disease. The study
achieved its primary objective, demonstrating that Thetanix was
well tolerated with a good safety profile.
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 subjects aged 16-18
with Crohn's disease. In the single-dose phase, eight subjects were
given a single dose of either Thetanix or placebo. In the
multiple-dose phase, 10 subjects were given either Thetanix or
placebo twice daily for seven consecutive days.
The Company also announces the publication of data demonstrating
the efficacy of Thetanix in pre-clinical models of inflammatory
bowel disease (IBD). The data, published in the journal
Inflammatory Bowel Diseases, showed that Thetanix demonstrated
strong efficacy on the primary readouts in two different
preclinical models with relevance to Crohn's disease, protecting
against weight loss, preventing histopathological changes in the
colon and attenuating inflammatory mediators.
Using an in vitro co-culture assay, a pirin-like protein (PLP),
produced by Thetanix, was also identified as a candidate effector
molecule. Recombinant PLP was shown to be protective against
colitis in a preclinical model and, like Thetanix, to act on
NF-<KAPPA>B signalling in vitro.
Dr. Alex Stevenson, 4D's Chief Scientific Officer, commented:
"These promising results add to the growing body of evidence on the
efficacy of Thetanix, further reinforcing its potential as a novel
treatment for Crohn's disease. Achieving the primary objective of
the Phase Ib study, demonstrating the safety and tolerability of
Thetanix, is an important milestone in the development of this
programme."
The journal article can be found here:
https://academic.oup.com/ibdjournal/advance-article-abstract/doi/10.1093/ibd/izy281/5095645
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. For more information, refer to
https://www.4dpharmaplc.com/.
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.
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contact rns@lseg.com or visit www.rns.com.
END
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