- Part A of the trial achieved the primary
endpoint of safety and tolerability
- Multiple secondary endpoints show positive
trends in improving asthma control, supporting progression into
Part B of the Phase I/II trial
- Company to host conference call and webcast
to discuss results today at 08:00 a.m. ET (1:00 p.m. GMT)
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 additional clinical data from Part A of its Phase I/II
trial of MRx-4DP0004, an orally-delivered single strain Live
Biotherapeutic being developed for the treatment of asthma. The
Company previously reported topline safety and efficacy data from
Part A, and today announces additional details of these
results.
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. Secondary
endpoints evaluating clinical activity include Asthma Control
Questionnaire (ACQ-6), use of short-acting beta agonist (SABA)
rescue medication, Asthma Quality of Life Questionnaire (AQLQ),
lung function, and exacerbations.
As previously announced, Part A met the primary endpoint and the
safety profile of MRx-4DP0004 was comparable to placebo. In
addition, MRx-4DP0004 showed activity across multiple secondary
endpoints compared to placebo, generating promising preliminary
signals of clinical activity which support progression into Part B
of the Phase I/II study. Part B is expected to enroll up to 90
patients and will assess clinical efficacy in addition to
exploratory immune and microbiome biomarkers.
“The further clinical results announced today are highly
encouraging. Beyond achieving the primary endpoint, we have seen
positive trends in multiple secondary endpoints of efficacy that we
will be assessing in Part B, including statistical significance at
all time points in what will be the primary endpoint in the Part B
phase of this trial,” commented Duncan Peyton, Chief Executive
Officer, 4D pharma. “These results further demonstrate the ability
of 4D pharma’s MicroRx platform to identify Live Biotherapeutics
that are able to drive systemic effects and deliver new treatments
to patients in need.”
MRx-4DP0004 Phase I/II Trial Overview and Results from Part
A Part A of the Phase I/II clinical trial enrolled 34 patients,
randomized 1:1 to receive oral MRx-4DP0004 (N=18) or placebo (N=16)
twice daily for 12 weeks, in addition to their usual maintenance
therapy of inhaled corticosteroids (ICS) with or without
long-acting beta agonist (LABA).
- MRx-4DP0004 achieved the primary endpoint of safety and
tolerability in combination with ICS and LABA. 61.1% of patients
receiving MRx-4DP0004 experienced any adverse event (AE) compared
to 75.0% of patients receiving placebo, of which only two were
possibly related to MRx-4DP0004. All AEs were mild or moderate in
severity. No serious adverse events (SAEs) related to treatment
were reported.
- At all timepoints throughout the treatment period, a
significantly greater proportion of MRx-4DP0004 treated patients
experienced reductions from baseline in Asthma Control
Questionnaire (ACQ-6) score, as compared to placebo. At end of
treatment, 83.3% of patients receiving MRx-4DP0004 experienced
reductions in ACQ-6 score, compared to 56.3% in the placebo arm.
The proportion of patients with reductions in ACQ-6 score at end of
treatment will be the primary endpoint for Part B of the Phase I/II
trial.
- Moreover, at end of treatment, 50.0% of patients receiving
MRx-4DP0004 experienced reductions from baseline in ACQ-6 scores of
0.5 or more, compared to 37.5% in the placebo arm.
- At the end of treatment, 50% of patients receiving MRx-4DP0004
reduced their use of SABA, compared to 18.8% of patients receiving
placebo. Overreliance on SABA rescue medication is associated with
a greater risk of exacerbations, hospitalizations and mortality,
and reduced SABA use is a key indicator of improved asthma
control.
- 50.0% of patients receiving MRx-4DP0004 experienced a
clinically meaningful increase in Asthma Quality of Life
Questionnaire (AQLQ) scores of ≥0.5 at end of treatment, compared
to 31.3% receiving placebo. MRx-4DP0004-treated patients’ quality
of life continued to improve over the treatment period.
- Mean measures of lung function including forced expiratory
volume in the first second (FEV1, percentage of predicted), peak
expiratory flow (PEF), and ratio of FEV1 to forced vital capacity
(FEV1/FVC) for both MRx-4DP0004 and placebo treatment arms
generally remained within normal ranges from baseline to end of
treatment.
- One of 18 patients (5.6%) randomized to MRx-4DP0004 experienced
an asthma exacerbation, compared to two of 16 patients (12.5%)
randomized to placebo.
Conference Call & Webcast Information 4D pharma will
host a conference call and live webcast at 8:00 a.m. ET (1:00 p.m.
GMT) today, Thursday January 27, 2022. To access the live webcast,
please visit the ‘Events’ section of the 4D pharma website at
www.4dpharmaplc.com. A replay of the webcast and accompanying
slides will be available on the 4D pharma website following the
event.
About MRx-4DP0004 MRx-4DP0004 is an oral,
immunomodulatory, single strain Live Biotherapeutic product. 4D
pharma has demonstrated the ability of MRx-4DP0004 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,
tolerability and efficacy 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 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.
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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version on businesswire.com: https://www.businesswire.com/news/home/20220127005200/en/
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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