- Topline data from Part A of asthma study
expected in 2H 2021
- Discontinuation of enrollment in Phase II
study of MRx-4DP0004 for the treatment of hospitalized patient with
COVID-19
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 completion of its target enrollment of 30 patients
for Part A of its Phase I/II clinical trial of MRx-4DP0004 in
patients with partly-controlled asthma. Following the completion of
enrollment of Part A, 4D pharma expects to announce topline results
from these patients in the second half of 2021.
4D pharma also announces the voluntary discontinuation of
enrollment in the Phase II study of MRx-4DP0004 for the treatment
of hospitalized patients with COVID-19 in the UK, in order to focus
on its core LBP pipeline candidates due to the increase in
vaccination rates, declining hospitalization rates, and progress in
the MRx-4DP0004 asthma clinical trial.
MRx-4DP0004 is an oral, immunomodulatory, single strain LBP. 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.
“The completion of enrollment in Part A of 4D pharma’s asthma
study is an important milestone for this program. This is expected
to provide further validation of the favorable safety profile of
LBPs as a novel class of drug across a wide range of indications,
including respiratory disease,” said Alex Stevenson, Chief
Scientific Officer, 4D pharma. “For the MRx-4DP0004 program, as
COVID-19 hospitalizations continue to decline with the increase in
vaccinations, the voluntary discontinuation of enrollment into our
COVID-19 study enables 4D pharma to focus our efforts and resources
on developing our novel LBP for the treatment of asthma. We look
forward to elucidating important findings regarding the potential
of our oral, gut-restricted, single strain LBPs to exert potent
effects on the human immune system with therapeutic effects in
organs and tissues away from the gut.”
The first-in-human Phase I/II trial is a two part, multi-center,
randomized, double-blind, placebo-controlled trial of MRx-4DP0004
in patients taking long-term medication for asthma. Patients
receive oral MRx-4DP0004 or placebo twice daily for 12 weeks.
The primary endpoint of Part A of the trial is safety and
tolerability. Secondary and exploratory endpoints for Part A,
include a range of clinical measures of lung function and quality
of life, and a suite of sputum and blood immune biomarkers.
Biomarker analyses will further enhance the understanding of
MRx4DP0004’s mechanism of action and inform 4D pharma’s development
strategy. Part A of the study has now completed its target
enrollment of 30 patients and 4D pharma expects to announce topline
results from these patients in 2H 2021.
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 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 timing of clinical trial enrolment and receipt of
clinical data, 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 of delays in the
receipt of clinical data, the safety and efficacy of MRx-4DP0004
and its Live Biotherapeutic drug candidates, 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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