TIDMDDDD
RNS Number : 6924L
4d Pharma PLC
17 May 2022
4D pharma Presents Late Breaking Abstract from Phase I/II Trial
of MRx-4DP0004 for the Treatment of Asthma at the American Thoracic
Society (ATS) 2022 International Conference
Leeds, UK, May 17, 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 the presentation of a late-breaking
poster on data from Part A of the Phase I/II trial of MRx-4DP0004
for the treatment of asthma. The poster is being presented at the
2022 American Thoracic Society (ATS) International Conference, May
13-18, 2022 in San Francisco, CA, US.
"The clinical results of MRx-4DP0004 treatment to date reinforce
4D pharma's success in using the MicroRx platform to select single
strain LBPs and generate clinical candidates with specific
immune-modulating therapeutic functionality. We are proud to share
with the asthma medical community our growing body of data
supporting the potential of MRx-4DP0004 as a novel oral treatment
for asthma. 4D pharma will further bolster these results as we
advance the Phase I/II trial into Part B," said Dr. Alex Stevenson,
Chief Scientific Officer of 4D pharma. "The effects of MRx-4DP0004
improving ACQ scores and reducing patients' reliance on SABA rescue
medication are very encouraging. Moving forward into the Part B
phase of this trial, 4D pharma aims to evaluate MRx-4DP0004 in
asthma patients with more symptomatic disease, expected to provide
a greater opportunity to demonstrate improvements."
The Company previously announced topline safety and efficacy
data from Part A of the trial, in addition to disclosing that this
portion of the trial met the primary endpoint of safety and
tolerability. In a late-breaking abstract and poster presentation
titled, " Safety, Tolerability and Preliminary Signals of Activity
in Adult Patients with Partly Controlled Asthma Treated with Live
Biotherapeutic MRx-4DP0004 as an Add-On Maintenance Therapy to
Inhaled Corticosteroids (ICS) With or Without Long-Acting Beta
Agonists (LABA)," 4D highlighted key safety and efficacy
findings:
Safety
- MRx-4DP0004 was safe and well-tolerated with no
treatment-related severe adverse events (AEs) or serious AEs
reported.
- The frequency of AEs and treatment discontinuations due to AEs were comparable to placebo.
Efficacy
- A significantly greater proportion of patients receiving
MRx-4DP0004 than those receiving placebo experienced a reduction in
Asthma Control Questionnaire (ACQ-6) scores from baseline at all
time points. At end of treatment 83.3% of subjects receiving
MRx-4DP0004 had improved ACQ-6 scores compared to 56.3% of those
receiving placebo, p=0.088.
- The proportion of MRx-4DP0004-treated patients with improved
ACQ-6 scores increased over the treatment period.
- A greater proportion of the MRx-4DP0004 arm than the placebo
arm experienced a reduction in total weekly use of short-acting
beta agonists (SABA) rescue medication at all time points.
- At the end of treatment period (day 85), 50% of patients
receiving MRx-4DP0004 reduced their use of SABA rescue medication
as compared to 18.8% for patients receiving placebo.
- At the end of treatment period (day 85), 50% of patients
receiving MRx-4DP0004 experienced clinically meaningful
improvements in Asthma Quality of Life Questionnaire (AQLQ) scores
of >=0.5 from baseline, compared to 31.3% of patients receiving
placebo.
- In the 12-week treatment period, there was one instance of
asthma exacerbation in the MRx-4DP0004 treatment arm, compared to
two instances in the placebo arm.
- Mean measures of lung function remained stable from baseline
and throughout the treatment period, determined by forced
expiratory volume (FEV1), ratio FEV1:forced vital capacity (FVC)
and peak expiratory flow (PEF).
The Phase I/II trial of MRx-4DP0004 is now progressing into Part
B, which will assess clinical and biomarker activity in up to 90
adult patients with partly controlled asthma. Following the
successful conclusion of Part A, 4D pharma intends to enroll
patients into Part B of the study who are more symptomatic than
those enrolled in Part A. 4D pharma expects the more symptomatic
patients to give even greater scope for treatment effects to be
observed. The primary endpoint of Part B will be the proportion of
patients with a reduction in ACQ-6 scores from baseline vs.
placebo, which was statistically significant at all time points
evaluated in Part A of the trial.
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. 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 (Merck & Co., Inc.,
Kenilworth, NJ, USA), to discover and develop Live Biotherapeutics
for vaccines.
Contact Information:
4D pharma
Investor Relations ir@4dpharmaplc.com
Singer Capital Markets - Nominated Adviser and Joint Broker
Philip Davies / James Fischer (Corporate Finance) +44 (0)20 7496
3000
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker
Dominic Wilson +44 (0)20 7332 2500
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
neil@ibcomms.agency / michelle@ibcomms.agency
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, use of the MicroRx(R) platform to identify candidates,
and the Company's next steps and progression of the Phase I/II
study, 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 present
expectations or projections. The foregoing factors and the other
risks that could cause actual results to differ materially include
risks relating to the efficacy of its Live Biotherapeutic drug
candidates including MRx-4DP0004, the risk that the Company changes
its expected strategy and plans, risk related to safety of
investigational therapeutics, clinical development risk, and those
additional risks and uncertainties described in the documents filed
by the Company with the US Securities and Exchange Commission
("SEC"). 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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