TIDMDDDD
RNS Number : 9931W
4d Pharma PLC
24 August 2022
4D pharma plc (in administration)
4D pharma Announces Publication of Preclinical Research Showing
Live Biotherapeutic MRx0006 Efficacy in Animal Model of Autism
Spectrum Disorder
Leeds, UK, August 24, 2022 - 4D pharma plc (AIM: DDDD) , a
pharmaceutical company leading the development of Live
Biotherapeutic products (LBPs), a novel class of drug derived from
the microbiome, today announces the publication of pre-clinical
research relating to its LBP MRx0006 for the treatment of autism
spectrum disorder (ASD).
The research, published in Brain, Behaviour and Immunity,
demonstrates the ability of single strain LBP MRx0006 to attenuate
core behavioural deficits in a mouse model of autism, improving
social deficits, repetitive and anxiety-like behaviours.
Mechanistically, MRx0006 increased in the brains of ASD mice the
expression of neuropeptide hormones known to regulate social and
anxiety behaviour. MRx0006 also modulated the fecal microbiome
metabolite profile in treated mice, which may underly the observed
increases in expression of neuropeptides and their receptors, and
the consequent improvements in behavioural outcomes.
"The publication of this research illustrates the continued
productivity of 4D pharma's MicroRx platform, and further
establishes 4D pharma as a pioneer in expanding the application of
live biotherapeutics to conditions of the gut-brain axis,"
commented Dr. Imke Mulder, Research Director, 4D pharma. "People
with autism spectrum disorder and their families are in need of new
treatment approaches, and the microbiome-gut-brain axis is
increasingly recognized as a key target. Importantly, with this
research we are moving the field beyond associations to demonstrate
the meaningful impacts that can be achieved by a single strain of
bacteria, and identifying mechanisms through which the gut
microbiome influences the central nervous system and
behaviour."
"To our knowledge MRx0006 is the first live biotherapeutic to
demonstrate the ability to target all three core behavioural
deficits central to ASD, representing a novel therapeutic
strategy," commented Dr Alex Stevenson, Chief Scientific Officer,
4D pharma. "Adding to our previous work in conditions of the
central nervous system such as Parkinson's disease, these results
further confirm the potential of human microbiota-derived
therapeutics in supporting mental health by modulating the
microbiota-gut-brain axis."
Sen et al., 'The live biotherapeutic Blautia stercoris MRx0006
attenuates social deficits, repetitive behaviour, and anxiety-like
behaviour in a mouse model relevant to autism' Brain, Behaviour and
Immunity, 2022, in press
https://doi.org/10.1016/j.bbi.2022.08.007
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 pharma 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(R) (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. A Phase I study of MRx0005 and MRx0029 in patients
with Parkinson's disease is expected to commence in 2022.
Additional preclinical-stage programs include candidates for CNS
disease, immune-inflammatory conditions and cancer. The Company has
a research collaboration with MSD (Merck & Co., Inc.,
Kenilworth, NJ, USA), to discover and develop Live Biotherapeutics
for vaccines.
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
Forward-Looking Statements
This announcement contains "forward-looking statements." All
statements other than statements of historical fact contained in
this announcement, including without limitation statements
regarding the efficacy of its Live Biotherapeutics including
MRx0006, use of the MicroRx(R) platform to identify candidates, and
the safety and efficacy of Live Biotherapeutics for the treatment
of conditions of the central nervous system (CNS), are
forward-looking statements within the meaning of Section 27A of the
United States Securities Act of 1933, as amended (the "Securities
Act"), and Section 21E of the United States Securities Exchange Act
of 1934, as amended (the "Exchange Act"). Forward-looking
statements are often identified by the words "believe," "expect,"
"anticipate," "plan," "intend," "foresee," "should," "would,"
"could," "may," "estimate," "outlook" and similar expressions,
including the negative thereof. The absence of these words,
however, does not mean that the statements are not forward-looking.
These forward-looking statements are based on the Company's current
expectations, beliefs and assumptions concerning future
developments and business conditions and their potential effect on
the Company. While management believes that these forward-looking
statements are reasonable as and when made, there can be no
assurance that future developments affecting the Company will be
those that it anticipates.
All of the Company's forward-looking statements involve known
and unknown risks and uncertainties, some of which are significant
or beyond its control, and assumptions that could cause actual
results to differ materially from the Company's present
expectations or projections. The foregoing factors and the other
risks that could cause actual results to differ materially include
risks relating to the efficacy of its Live Biotherapeutic drug
candidates including MRx0006, risk related to safety of
investigational therapeutics, pre-clinical and clinical development
risk, and those additional risks and uncertainties described in the
documents filed by the Company with the US Securities and Exchange
Commission ("SEC"). The Company wishes to caution you not to place
undue reliance on any forward-looking statements, which speak only
as of the date hereof. The Company undertakes no obligation to
publicly update or revise any of its forward-looking statements
after the date they are made, whether as a result of new
information, future events or otherwise, except to the extent
required by law.
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