Results demonstrate changes in gut microbiome
structure following administration of Blautix in both IBS-C and
IBS-D patients
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 new fecal microbiome analyses from the completed Phase II
trial of Blautix® (MRx1234) as a treatment for irritable bowel
syndrome with constipation (IBS-C) or with diarrhea (IBS-D). The
new data will be presented in an ePoster at Gastro 2021, held from
December 9-11, 2021.
The Phase II study was a multicenter, randomized, double-blind
trial that enrolled 353 patients with IBS-C or IBS-D. Patients were
treated for eight weeks with either Blautix or placebo. Microbiome
composition and microbial co-occurrence network analyses were
performed on 949 fecal samples from 260 subjects from the four
study treatment groups (IBS-C Blautix-treated, IBS-C
placebo-treated, IBS-D Blautix-treated, IBS-D placebo-treated) at
baseline (week 0), mid-treatment (week 4), end of treatment (week
8), and wash-out (week 12).
Treatment with Blautix led to structural changes in the gut
microbiota of patients with both IBS-C or IBS-D. These changes did
not occur in placebo treatment groups. Blautix treatment led to
greater increases in interconnectivity between taxa than in the
placebo-treated group, also in both IBS-C and IBS-D cohorts.
Blautix (Blautia hydrogenotrophica) was associated with a
subnetwork of multiple taxa showing high connectivity and
ultimately impacting the overall microbiome structure, also in both
IBS-C and IBS-D patients.
4D pharma previously announced positive initial topline results
from the Phase II trial in October 2020 and presented further
positive results of additional post-hoc analyses at Digestive
Disease Week (DDW) in May 2021. The Gastro 2021 presentation is
available via the Posters & Presentations area of the 4D pharma
website at www.4dpharmaplc.com.
“The additional microbiome analyses from the Phase II study
represent an interesting and important finding, further
establishing the mechanisms through which Blautix exerts its
beneficial effects in both IBS-C and IBS-D. The results show that
administration of a single strain Live Biotherapeutic can have
significant positive effects on the composition and structure of
the microbiome in these patients,” said Prof. Eamonn Quigley, Head
of Gastroenterology and Hepatology at Houston Methodist Hospital
and the Study’s Chief Investigator. “As a result, Blautix is an
exciting novel treatment option for IBS patients. Its activity
across multiple subtypes, further demonstrated with today’s data,
is particularly remarkable.”
“These microbiome analyses are an important addition to our
already significant clinical data package for Blautix. These
findings from the Phase II trial, coupled with the positive
outcomes of the previous post-hoc analysis, demonstrate that
Blautix could provide a significant solution to address the high
unmet needs of millions of patients globally with IBS,” said Dr.
Alex Stevenson, Chief Scientific Officer, 4D pharma. “Our
complimentary MicroRx and MicroDx platforms enable this level of
detail regarding the mechanism of action of Blautix, along with
those of 4D pharma’s pipeline of other Live Biotherapeutics across
multiple indications. We continue to await feedback from the FDA
which will inform our strategy for progressing Blautix as a novel
treatment option for IBS patients in need.”
The US Food and Drug Administration (FDA) has updated 4D pharma
regarding ongoing substantial delays to its review processes as a
result of the COVID-19 pandemic. As a result 4D pharma continues to
await feedback from the FDA regarding the results of its Phase II
study of Blautix for the treatment of IBS and the Company’s
questions ahead of progression into any pivotal program.
About the Blautix® Phase II clinical trial
The Blautix® Phase II clinical trial (ClinicalTrials.gov
identifier: NCT03721107) is a multicenter, randomized,
placebo-controlled study that enrolled a total of 353 patients with
IBS-C or IBS-D with eligible baseline data (158 and 195 patients,
respectively). Patients in each cohort were randomized 1:1 to
receive either Blautix or placebo; in total, 76 IBS-C patients and
94 IBS-D patients received Blautix treatment. Blautix or placebo
was administered orally as two capsules, twice daily for eight
weeks.
About Blautix®
Blautix® is a single strain Live Biotherapeutic product (LBP),
being developed as a treatment for both IBS-C and IBS-D.
Pre-clinical studies demonstrated its ability to address visceral
hypersensitivity and other symptoms of IBS and increase microbiome
diversity. A Phase I study in healthy volunteers and IBS patients
showed that Blautix was well tolerated and an improvement in
symptoms was also reported relative to placebo. The Phase II
BHT-II-002 trial demonstrated an impact on overall response with
regard to bowel habit and abdominal pain in IBS-C and IBS-D.
Blautix was well tolerated, with a safety profile comparable to
placebo.
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 the efficacy of Live Biotherapeutics including Blautix®,
its ability to impact the treatment of irritable bowel syndrome,
regulatory interactions, and the utility of the MicroRx® and
MicroDx® platforms 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
activity and efficacy of its Live Biotherapeutic drug candidates
including Blautix, interactions with regulatory bodies including
the US FDA, 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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