- IND clearance marks the expansion of 4D
pharma’s clinical-stage pipeline of single strain Live
Biotherapeutics into neurology
- First US FDA IND clearance for a Live
Biotherapeutic for Parkinson’s disease
4D pharma plc (AIM: DDDD,
NASDAQ: LBPS), a pharmaceutical company leading the development
of Live Biotherapeutic products (LBPs), a novel class of drug
derived from the microbiome, today announces that the U.S. Food and
Drug Administration (FDA) has cleared investigational new drug
(IND) applications for two Live Biotherapeutics (LBPs), MRx0005 and
MRx0029, for the treatment of Parkinson’s disease. The Company
expects to initiate a first-in-human Phase I clinical trial in
people with Parkinson’s disease in mid-2022.
“Entering the clinic with our novel CNS programs stemming from
our proprietary MicroRx platform will represent an important step
for 4D pharma’s continued growth and leadership in the microbiome
field. We believe MRx0005 and MRx0029 are the first ever Live
Biotherapeutic products for Parkinson’s to enter the clinic,” said
Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. “Current
treatments focus on symptoms but do not address the underlying
causes of neurodegeneration. Patients and clinicians are in need of
new, more effective treatment options, and the gut-brain axis is an
exciting area of innovation with the potential to change the way we
approach Parkinson’s treatment. We believe that our LBPs MRx0005
and MRx0029, which each have different mechanisms of action worthy
of investigation, provide a unique opportunity to address the high
unmet needs of those living with Parkinson’s disease.”
“Parkinson’s disease is a devastating condition impacting more
than 10 million people globally. As the global population ages,
this number will continue to increase. There is growing evidence
suggesting that the gut-brain axis could be key to developing new
treatments for several neurological disorders, particularly
Parkinson’s disease,” said Professor Peter LeWitt, Sastry
Foundation Endowed Chair in Neurology at Wayne State University
School of Medicine, and Coordinating Investigator of the Phase I
clinical trial. “Oral, gut-targeted treatments such as 4D pharma’s
Live Biotherapeutics MRx0005 and MRx0029 offer an exciting new way
for possibly slowing Parkinson’s disease progression. The
development of these potential new therapies is really breaking new
ground in the field.”
MRx0005 and MRx0029 are two unique single strain Live
Biotheraputic candidates, which have been shown pre-clinically to
have positive impacts on multiple key aspects of Parkinson’s
disease pathology, including gut barrier integrity,
neuroinflammation, oxidative stress and neuroprotection. In animal
models of Parkinsonian syndrome, 4D pharma demonstrated that
MRx0005 and MRx0029, respectively protected against the loss of
dopamine metabolites and dopamine-producing neurons in the
brain.
4D pharma expects to initiate a Phase I clinical trial in
mid-2022. The multi-center, randomized, double-blind,
placebo-controlled study will evaluate the safety and tolerability
of MRx0005 or MRx0029 in separate cohorts of patients with
Parkinson’s disease. In addition to safety, the study will measure
biomarkers relating to the mechanisms of action of the candidate
LBPs.
4D pharma is collaborating with Parkinson's UK, a non-profit
organization focused on advancing the understanding of Parkinson's
disease and improving treatments, and has established a Patient
Advisory Board (PAB) comprised of people living with Parkinson's.
Supported by Parkinson's UK, the PAB provides a valuable
patient-centric perspective to 4D pharma as it advances its novel
Live Biotherapeutics into the clinic to treat neurodegenerative
conditions such as Parkinson's. The PAB will also focus on raising
awareness of the issues people with Parkinson's face with current
treatment options. In addition, 4D pharma is an Industry Partner of
the Parkinson's Progression Markers Initiative (PPMI), a landmark
study sponsored by The Michael J. Fox Foundation to better
understand Parkinson's disease and to identify, develop, and
validate biomarkers of Parkinson's disease progression to further
the development of disease-modifying therapies.
About MRx0005 and MRx0029
MRx0005 and MRx0029 are oral single strain Live Biotherapeutic
products in development for the treatment of neurodegenerative
conditions such as Parkinson’s disease via the gut-brain axis.
Discovered using 4D pharma’s MicroRx® platform, both have been
shown pre-clinically to reduce neuroinflammation including
inflammation induced by α-synuclein, and to protect neurons from
oxidative stress-induced death. MRx0005 has been shown to
upregulate expression of neuroactive molecules and their receptors
in vivo, and protected against loss of dopamine metabolites in the
brains of mice with induced parkinsonian syndrome. Impaired
intestinal barrier function and intestinal permeability is a common
symptom of Parkinson’s disease thought to potentially contribute to
the onset or progression of the condition, and MRx0029 has been
shown to improve intestinal epithelial integrity. MRx0029 has also
been shown to induce the differentiation of dopaminergic neuronal
phenotype in vitro, and in an animal model of Parkinson’s disease
protected against the loss of dopaminergic neurons. In 2022, 4D
pharma plans to commence a Phase I clinical trial of both MRx0005
and MRx0029, separately, in people with Parkinson’s disease.
About Parkinson’s disease
Parkinson’s disease is a progressive neurodegenerative condition
caused by the loss of dopamine-producing (dopaminergic) neurons in
the brain resulting in characteristic motor symptoms of tremor,
stiffness, slowed movement and impaired balance and coordination. A
number of non-motor symptoms often precede the onset of motor
symptoms by years, and gastrointestinal symptoms such as
constipation and alterations of the enteric nervous system are
experienced by a majority of Parkinson’s patients. Parkinson’s
disease is the second most common age-related neurodegenerative
disorder after Alzheimer’s disease, affecting an estimated ten
million people worldwide. Current treatments focus on replacing
dopamine deficiency in the brain or addressing particular non-motor
symptoms. However, these treatments are associated with serious
side effects and their efficacy can wear off over time. There are
currently no approved disease-modifying treatments which prevent,
slow or reverse the underlying neurodegenerative processes.
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®, 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® 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, 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.
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 Live Biotherapeutics including MRx0005
and MRx0029, their ability to impact the treatment of Parkinson’s
disease, and the expected timing of the Company’s Phase I clinical
trial, 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 historical
experience and its present expectations or projections. The
foregoing factors and the other risks and uncertainties that affect
the Company's business, including the risks relating to the
efficacy of its Live Biotherapeutic drug candidates including
MRx0005 and MRx0029, risk related to safety of investigational
therapeutics, clinical development risk, and those additional risks
and uncertainties described the documents filed by the Company with
the US Securities and Exchange Commission ("SEC"), should be
carefully considered. 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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