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RNS Number : 3570V
4d Pharma PLC
13 December 2021
4D pharma announces positive topline results from Part A of
Phase I/II trial of MRx-4DP0004 for the treatment of asthma
Part A of the study meets primary endpoint of safety and
tolerability
Achieved multiple key secondary endpoints relating to improved
asthma control compared to placebo
Leeds, UK, December 13, 2021 - 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 positive topline results from Part
A of phase I/II clinical trial of MRx-4DP0004, an orally-delivered
single strain Live Biotherapeutic being developed for the treatment
of asthma.
The Phase I/II trial is a multi-center, double-blind,
placebo-controlled study in patients with partly controlled asthma
taking long-term medication. The primary endpoint of Part A was to
evaluate the safety and tolerability of MRX-4DP0004 with secondary
endpoints evaluating clinical activity.
Part A met the primary endpoint and the safety profile of
MRx-4DP0004 was comparable to placebo. No serious adverse events
(SAEs) related to treatment were reported.
In addition to the achieving the primary endpoint, MRx-4DP0004
generated promising signals of clinical activity, which supports
progression into Part B of the study. Part B is expected to enroll
up to 90 patients, informed by the clinical signals identified in
Part A.
"The results from Part A of 4D pharma's Phase I/II study of
MRx-4DP0004 as a treatment for asthma are an important step forward
in our development of a new safe oral therapeutic for asthma
patients," said Dr. Alex Stevenson, Chief Scientific Officer of 4D
pharma. "Not only do the results support the excellent safety
profile shown to date across our clinical pipeline of Live
Biotherapeutics for a variety of indications, but also demonstrate
our ability to identify and develop single strain LBPs with potent
systemic activity using our MicroRx(R) platform. MRx-4DP0004 has
shown encouraging activity in key secondary endpoints of clinical
activity, and this data will help to guide the selection of
patients for future development of the product."
"For a study of this size in a relatively mild and heterogeneous
population the signals are encouraging and if the effects on ACQ
and SABA are maintained in larger numbers of participants and
confirmed in later studies then could be clinically meaningful,"
said Prof. Chris Brightling, NIHR Senior Investigator and Clinical
Professor in Respiratory Medicine at the University of Leicester.
"Asthma is a heterogeneous disease of numerous clinical phenotypes.
Current therapeutic options are not effective in all severe
patients and thus there remains a significant unmet need for new
treatment options. I look forward to the results of the Part B
expansion phase, which will help to further identify an optimal
target patient population for future development of
MRx-4DP0004."
Trial overview and Topline Results from Part A
Part A enrolled 34 patients, randomized 1:1 to receive oral
MRx-4DP0004 or placebo twice daily for 12 weeks, in addition to
their usual maintenance therapy of inhaled corticosteroids (ICS)
with or without long-acting beta agonist (LABA). Part A of the
study was not powered for statistical significance and 29 patients
were evaluable for secondary endpoints of clinical activity.
-- MRx-4DP0004 achieved the primary endpoint of safety and
tolerability in combination with ICS and LABA.
-- The safety profile of MRx-4DP0004 was comparable to placebo
and no serious adverse events (SAEs) related to treatment were
reported.
-- A greater proportion of patients receiving MRx-4DP0004
reduced their dependence on short-acting beta agonist (SABA) rescue
medication compared to placebo. Reduced SABA use is a key indicator
of improved asthma control.
-- A greater proportion of patients receiving MRx-4DP0004 had a
clinically meaningful increase in Asthma Quality of Life
Questionnaire (AQLQ) scores of >=0.5 at end of treatment,
compared to placebo.
-- MRx-4DP0004 achieved a greater mean change from baseline in
ACQ-6 score than placebo at end of treatment. ACQ-6 is a
well-established and widely used scale to measure asthma
control.
-- In addition, at end of treatment, a greater proportion of
patients receiving MRx-4DP0004 experienced clinically meaningful
reductions from baseline in ACQ-6 scores of >=0.5, than in the
placebo arm
-- Two of 16 patients randomized to placebo experienced asthma
exacerbations, compared to one of 18 patients randomized to
MRx-4DP0004.
About MRx-4DP0004
MRx-4DP0004 is an oral, immunomodulatory, single strain Live
Biotherapeutic product. 4D pharma has demonstrated MRx-4DP0004's
ability to reduce airway inflammation in a pre-clinical model of
severe asthma. This is achieved through a concurrent reduction in
both neutrophilic and eosinophilic infiltration and inflammation.
MRx-4DP0004 is currently being evaluated in a two-part, randomized,
double-blinded, placebo-controlled study evaluating the safety and
tolerability of MRx-4DP0004 in patients with partly controlled
asthma (Clinical Trial identifier: NCT03851250).
About Asthma
Asthma is an inflammatory disease of the lungs characterized by
recurring symptoms, reversible airflow obstruction, and
bronchospasm. Asthma affects 300 million people globally. Between
5-10% of asthma patients have the severe form of the disease, which
is refractory to steroid treatment and cannot be controlled with
high-intensity treatments and accounts for more than 50% of asthma
associated healthcare costs. There is a growing body of evidence
linking the gut microbiome to the development of asthma. The global
asthma therapeutics market is projected to reach $23.1 billion by
2023.
In severe asthma, airway inflammation can be predominantly
eosinophilic, neutrophilic or mixed. Whilst a number of biologics
have recently been approved to treat patients with eosinophilic
disease, there are currently no approved therapies for patients who
present with a neutrophilic phenotype.
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's Live Biotherapeutic Products are orally delivered single
strains of bacteria that are naturally found in the healthy human
gut. The Company has six clinical studies in progress, namely a
Phase II clinical study of Blautix(R) in Irritable Bowel Syndrome
(IBS), 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, and a
Phase I/II study of MRx-4DP0004 in asthma. 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
Duncan Peyton, Chief Executive Officer +44 (0)113 895 0130
Investor Relations ir@4dpharmaplc.com
Singer Capital Markets - Nominated Adviser and Joint Broker +44
(0)20 7496 3000
Philip Davies / James Fischer (Corporate Finance)
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332
2500
Dominic Wilson
Stern Investor Relations
Julie Seidel +1-212-362-1200
Julie.seidel@sternir.com
Image Box Communications
Neil Hunter / Michelle Boxall +44 (0)20 8943 4685
6 Degrees
Lynne Dardanell +1-336-202-9689
ldardanell@6degreespr.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
MRx-4DP0004, its ability to impact the treatment of asthma, unmet
medical need in asthma, and effectiveness of the MicroRx platform
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
MRx-4DP0004, 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
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END
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