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
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® 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®, 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® in Irritable Bowel Syndrome
(IBS), 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, 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.
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
required by law.
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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
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