4d Pharma PLC Blautix Phase II Clinical Trial Results Published (5007G)
November 16 2022 - 1:00AM
UK Regulatory
TIDMDDDD
RNS Number : 5007G
4d Pharma PLC
16 November 2022
4D pharma's Blautix(R) Phase II Clinical Trial Results Published
in Alimentary Pharmacology & Therapeutics
Leeds, UK - November 15, 2022 - 4D pharma plc (AIM: DDDD) (in
administration), a pharmaceutical company leading the development
of Live Biotherapeutic products (LBPs), a novel class of drug
derived from the microbiome, today announced the publication in the
journal Alimentary Pharmacology & Therapeutics of the Phase II
clinical data for LBP Blautix(R) (MRx1234) for the treatment of
irritable bowel syndrome.
The results highlight the positive effects of Blautix(R) on key
regulator-defined clinical symptoms of IBS, altered bowel habits
and abdominal pain, both in patients with IBS with predominant
constipation (IBS-C) or IBS with predominant diarrhoea (IBS-D).
Blautix was well tolerated, with a safety profile comparable to
placebo.
"We are pleased to be sharing our innovative clinical findings
in such a respected medical research journal," commented Alex
Stevenson, Chief Scientific Officer, 4D pharma. "Irritable bowel
syndrome remains a significant unmet medical need, with many
patients failing to derive adequate relief from currently available
symptomatic treatments and significant side effects associated with
their modes of action. Complemented by previous research by 4D
pharma and others, these clinical results support the potential for
Blautix(R) , a single strain Live Biotherapeutic Product, to
address the underlying causes of this highly debilitating
condition."
"This study represents one of the first, if not the first,
clinical trial of a live biotherapeutic in irritable bowel
syndrome," commented Professor Eamonn Quigley, Head of
Gastroenterology and Hepatology at Houston Methodist Hospital and
the Study's Chief Investigator. "While the primary outcome was not
achieved, results in secondary outcomes and post-hoc analyses
revealed signals supportive of efficacy and provide some confidence
that this may represent a new approach to the management of this
challenging disorder."
Quigley et al., 'Efficacy and safety of the live biotherapeutic
product MRx1234 in patients with irritable bowel syndrome: a
multicentre, randomised, phase 2 trial' Alimentary Pharmacology and
Therapeutics, 2022
https://onlinelibrary.wiley.com/doi/epdf/10.1111/apt.17310
On 24 June 2022, David Pike and James Clark of Interpath
Advisory were appointed as administrators of 4D pharma plc. The
administrators have had no oversight of or involvement in the
preparation of the journal publication nor in any materials which
will be circulated in advance of or following publication.
Therefore, the administrators make no statement or representation
in respect of the materials shared or discussed in advance of or
following publication.
About Blautix(R)
Blautix(R) is a single strain Live Biotherapeutic product (LBP),
being developed as a treatment for irritable bowel syndrome (IBS).
Pre-clinical studies demonstrated its ability to address visceral
hypersensitivity and other symptoms of IBS and increase microbiome
diversity. A Phase II randomized controlled clinical trial
demonstrated an impact on overall response with regards to bowel
habit and abdominal pain in both patients with IBS with
constipation (IBS-C) or IBS with diarrhoea (IBS-D). Blautix(R) was
well tolerated, with a safety profile comparable to placebo.
About 4D pharma
4D pharma 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 Live Biotherapeutics based
on a deep understanding of function and mechanism.
4D pharma's Live Biotherapeutic products (LBPs) are orally
delivered single strains of bacteria that are naturally found in
the healthy human gut. The Company has five clinical programs,
namely a Phase I/II study of MRx0518 in combination with KEYTRUDA
(pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a
neoadjuvant setting for patients with solid tumors, a Phase I study
of MRx0518 in patients with pancreatic cancer, a Phase I/II study
of MRx-4DP0004 in asthma, and Blautix(R) in Irritable Bowel
Syndrome (IBS) which has completed a successful Phase II trial.
Preclinical-stage programs include candidates for CNS disease such
as Parkinson's disease and other neurodegenerative conditions. The
Company has a research collaboration with MSD, a tradename of Merck
& Co., Inc., Kenilworth, NJ, USA, to discover and develop Live
Biotherapeutics for vaccines.
For more information, refer to https://www.4dpharmaplc.com
Contact Information:
4D pharma
4dpharma@interpathadvisory.com
Singer Capital Markets - Nominated Adviser and Joint Broker
Philip Davies / James Fischer (Corporate Finance) +44 (0)20 7496
3000
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