TIDMDDDD
RNS Number : 1069R
4d Pharma PLC
01 July 2022
4D PHARMA PLC ("4D pharma") IS TEMPORARILY PAUSING RECRUTMENT
INTO ONGOING CLINICAL TRIALS
Leeds, UK, 1 July, 2022 - 4D pharma plc (AIM: DDDD, NASDAQ:
LBPS), a pharmaceutical company leading the development of Live
Biotherapeutic products (LBPs), a novel class of drugs derived from
the microbiome, today announces that following the appointment of
administrators on 24 June 2022, recruitment of new patients into
ongoing clinical studies will be temporarily paused. The studies
impacted are:
1) the Phase I/II study of MRx0518, in combination with
KEYTRUDA(R) (pembrolizumab), in patients with solid tumors. This
study is currently in Part B and has met its primary efficacy
endpoint early in the renal cell carcinoma group, as announced on
23 March 2022, having previously successfully completed Part A as
announced on 11 May 2020;
2) the Phase II clinical trial of MRx0518, in combination with
BAVENCIO(R) (avelumab), in patients with urothelial carcinoma;
3) the Phase I study of MRx0518 in patients with pancreatic cancer;
4) the Phase I/II study of MRx-4DP0004 in patients with asthma.
Part A of this study was successfully completed as announced on 13
December 2021 ; and
5) the Phase I study of MRx0005 or MRx0029 in patients with Parkinson's disease.
4D pharma is working with the administrators to enable an exit
from administration as soon as possible and, in the event that the
company does exit administration, currently plans to recommence
recruitment so long as additional capital funding is secured.
Further announcements will be made in due course.
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. In addition to those programs listed above,
there are two further clinical stage programs, namely Blautix(R)
which is in development for the treatment of irritable bowel
syndrome (IBS), and which has successfully completed a Phase II
trial, and MRx0518 in patients with solid tumours, which
successfully completed Part A as announced on 9 November 2020.
Additional nonclinical-stage programs of LBPs include therapies for
central nervous system (CNS) diseases, immune-inflammatory
conditions and cancer. 4D pharma 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 timing of studies, 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 4D pharma's current expectations, beliefs and assumptions
concerning future developments and business conditions and their
potential effect on 4D pharma. While management believes that these
forward-looking statements are reasonable as and when made, there
can be no assurance that future developments affecting 4D pharma
will be those that it anticipates.
All of 4D pharma'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 4D pharma's historical experience and its
present expectations or projections. The foregoing factors and the
other risks and uncertainties that could cause actual results to
differ materially include the ability of 4D pharma to exit from
administration and potential changes in its recruitment plan if
additional capital funding is secured. 4D pharma wishes to caution
you not to place undue reliance on any forward-looking statements,
which speak only as of the date hereof. 4D pharma 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.
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
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END
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