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RNS Number : 7740Z
4d Pharma PLC
27 January 2022
4D pharma announces additional positive data from Part A of the
Phase I/II trial of MRx-4DP0004 for the treatment of asthma
- 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)
Leeds, UK, January 27, 2022 - 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(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. 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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