TIDMDDDD
RNS Number : 5105Z
4d Pharma PLC
24 May 2021
4D pharma Presents Additional Positive Results of Phase II Study
of Blautix(R) for the Treatment of Irritable Bowel Syndrome
New data demonstrating clinical activity in both IBS-C and IBS-D
was presented at Digestive Disease Week 2021
Company to host webcast on Tuesday, May 25, 2021 at 12:00 p.m.
EDT
Leeds, UK, May 24, 2021 - 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 positive data from its
completed Phase II trial of LBP Blautix(R) in subjects with
irritable bowel syndrome with constipation (IBS-C) or with diarrhea
(IBS-D).
The data has been presented in a poster session at Digestive
Disease Week (DDW), on May 22, 2021, by Professor Eamonn Quigley,
M.D., Head of Gastroenterology and Hepatology at Houston Methodist
Hospital, Professor of Medicine at Weill Cornell Medical, and Chief
Investigator of the study.
4D pharma previously announced topline efficacy and safety
results from the trial, conducted in the US, UK and Ireland, in
October 2020. Further analysis of the data has revealed strong and
statistically significant activity on the key symptom of bowel
habit, a potential approvable primary endpoint per regulatory
guidelines. In addition, analysis of the data by geographical
region shows that earlier topline results were impacted by an
unusually high placebo response in patients in the UK and Ireland,
and enhanced positive signals were seen in the larger US
population.
Single strain LBP Blautix is the first therapeutic globally to
have demonstrated efficacy in both IBS-C and IBS-D. The clinically
meaningful overall response rates and improvements in bowel habit
in both IBS-C and IBS-D in this signal finding Phase II trial, in
spite of an unexpectedly high placebo response in certain patient
groups, are highly encouraging for subsequent larger studies with
increased statistical power.
"Following the announcement of the topline results in October,
4D pharma has been able to review the data in more detail. We have
also discussed the results with internationally renowned key
opinion leaders and patient groups. We are encouraged by the
positive outcomes of this additional analysis, and we strongly
believe that this signal finding study supports the continued
development of Blautix as a novel treatment for IBS," said Dr. Alex
Stevenson, Chief Scientific Officer, 4D pharma. "The Phase II
results, in conjunction with regulatory guidance and KOL
discussions, provide a clear and viable path forward for 4D pharma
to continue to develop Blautix to address a significant unmet need.
Topline results were significantly impacted by an unusually high
placebo response in certain geographical patient groups. Despite
this, the activity of Blautix relative to placebo in this Phase II
study is competitive with approved IBS therapeutics. We are pleased
to now share our additional positive findings following more
detailed analysis of the clinical data. With the vital learnings we
have gained, we are now even more enthusiastic about the chances of
success in subsequent, larger, well-powered studies."
"The idea of a single, safe, effective therapeutic able to
address multiple sub-types of IBS is a hugely exciting proposition
for both patients and clinicians. The level of efficacy achieved by
Blautix in IBS-C and IBS-D is very encouraging for larger pivotal
studies," said Professor Eamonn Quigley, Chief Investigator of the
study. "Importantly, the Phase II study used robust enrolment
criteria and endpoints, setting the program up well for any pivotal
studies. The efficacy and clean safety profile of Blautix presents
an attractive package and a competitive position compared to what
is currently available to prescribe to IBS patients."
The signal finding Phase II study was a multi-centre,
randomised, double-blind, placebo-controlled study. It enrolled 353
patients in the US, UK and Ireland with IBS-C or IBS-D as defined
by the Rome IV criteria, and moderate or severe IBS symptom
severity score (IBS-SSS) of >=175 at screening (158 IBS-C and
195 IBS-D patients). Each sub-type cohort was randomized 1:1 to
receive oral Blautix or placebo, two capsules twice daily, for 8
weeks. The study was designed to generate signals of activity in
both IBS-C and IBS-D and to define key parameters for a pivotal
program.
The previously announced overall responder rate (ORR) primary
endpoint was assessed in all randomized subjects (N=353). ORR was
also assessed in all patients evaluable for efficacy at eight weeks
(N=316). Bowel habit and abdominal pain, the two components of the
overall responder endpoint, were also analyzed independently.
Post-hoc analyses of efficacy readouts by geographic region and
gender subsets were also conducted.
Additional Efficacy Data
In the post-hoc sub-group analysis, in evaluable patients
(IBS-C, N=147; IBS-D N=169), Blautix demonstrated the
following:
-- Statistically significant improvements in bowel habit in
IBS-D (Blautix 62.0% vs placebo 47.4%, p=0.042), and a strong
effect nearing significance in IBS-C (Blautix 53.8% vs placebo
39.3%, p=0.054) in patients across all geographic regions.
-- Consistent improvements in bowel habit in patients receiving
Blautix between geographic regions.
-- An enhanced effect size in US patients due to a lower placebo
response, achieving a statistically significant improvement in
bowel habit in both IBS-C (Blautix 62.3% vs placebo 42.6%, p=0.028)
and IBS-D (Blautix(R) 53.7% vs 28.6%, p=0.014).
-- Patients receiving Blautix reported progressive decreases in
abdominal pain intensity over the treatment period. After eight
weeks of treatment, evaluable IBS-C and IBS-D patients receiving
Blautix reported an average decrease from baseline in weekly
abdominal pain scores of 29.7% and 34.4%, respectively.
-- Analysis of ORR by geographic region demonstrated comparable
response rates in patients receiving Blautix regardless of region.
This analysis did, however, identify a markedly greater placebo
response in patients enrolled in the UK and Ireland compared to
those enrolled in the US.
-- In evaluable US patients, Blautix demonstrated a more than
two-fold greater ORR than placebo in IBS-D (Blautix 29.3% vs
placebo 14.3%, p=0.07), and a clinically meaningful 73% improvement
in ORR over placebo in IBS-C (Blautix 28.3% vs placebo 16.4%,
p=0.096).
-- Placebo response rates were notably higher in UK and Ireland
patients with IBS-C (Blautix 22.2% vs placebo 20.0%, p=0.5) and
IBS-D (Blautix 25.6% vs placebo 27.5%, p=0.5).
-- A particularly strong, statistically significant overall
response rate was observed in female IBS-D subjects across all
regions (Blautix 34.6% vs placebo 19.0%, p=0.05). This effect was
enhanced and highly significant in US female IBS-D subjects
(Blautix 37.9% vs placebo 9.4%, p=0.01).
Subjects in all regions met the same enrolment criteria, and
there were no notable differences in baseline characteristics
between regions. The Company has discussed the high placebo
response in UK and Ireland patients with international key opinion
leaders (KOLs) and IBS patient advocate groups, and identified a
number of potential factors relating to placebo response and
unrelated to study drug effectiveness in different populations.
Safety Data
As previously reported, Blautix demonstrated a safety profile
comparable to placebo, with no treatment-related severe adverse
events or serious adverse events. The most common adverse events
were mild or moderate in severity, and were limited to (IBS-C and
IBS-D cohorts combined) upper respiratory tract infection (3.9% vs
placebo 3.7%), nasopharyngitis (3.9% vs placebo 1.1%), diarrhea
(3.4% vs placebo 1.1%) and abdominal pain (2.3% vs placebo
2.1%).
The Company continues to evaluate the Blautix Phase II data and
plans to engage in regulatory discussions in the second half of
2021.
A copy of the poster is available via the Posters &
Publications area of the 4D pharma website at www.4dpharmaplc.com
.
Conference Call and Webcast Details
4D pharma will host a virtual event to review the additional
data presented at DDW 2021, and how this relates to the current IBS
treatment landscape. The event will take place on Tuesday, May 25,
2021 at 5:00pm BST (12:00pm EDT). The event will feature a
presentation from 4D pharma management followed by an analyst
Q&A session.
A live webcast of the event will be available via the Events
section of the 4D pharma website at www.4dpharmaplc.com . To access
the call, please dial +1-760-294-1674 (United States) or
+44-203-059-58-69 (United Kingdom) and reference Conference ID
20210360. A replay of the webcast will be available following the
event.
About Blautix(R)
Blautix(R) 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. A Phase II trial
demonstrated an impact on overall response with regards to bowel
habit and abdominal pain in both IBS-C and IBS-D. Blautix was well
tolerated, with a safety profile comparable to placebo. Further
information on the Phase II study can be found at
ClinicalTrials.gov Identifier: NCT03721107.
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(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 six clinical programmes,
namely a Phase I/II study of MRx0518 in combination with KEYTRUDA
(pembrolizumab) in solid tumours, a Phase I study of MRx0518 in a
neoadjuvant setting for patients with solid tumours, a Phase I
study of MRx0518 in patients with pancreatic cancer, a Phase I/II
study of MRx-4DP0004 in asthma, a Phase II study of MRx-4DP0004 in
patients hospitalised with COVID-19, and Blautix(R) in Irritable
Bowel Syndrome (IBS) which has completed a successful Phase II
trial. Preclinical-stage programmes 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 4D's pharma's development plans for Blautix, 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 could
cause actual results to differ materially include the safety and
efficacy of its Live Biotherapeutic Product drug candidates
including Blautix(R), timelines for regulatory engagement, the need
for additional safety and efficacy data to support regulatory
approval, and those additional risks and uncertainties described
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.
Contact Information:
4D pharma
Investor Relations: ir@4dpharmaplc.com
N+1 Singer - Nominated Adviser and Joint Broker +44 (0)20 7496
3000
Philip Davies / Iqra Amin / James Fischer (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332
2500
Dominic Wilson / Phil Walker
Stern Investor Relations, Inc. +1-212-362-1200
Julie Seidel Julie.seidel@sternir.com
Image Box Communications +44 (0)20 8943 4685
Neil Hunter / Michelle Boxall
neil@ibcomms.agency / michelle@ibcomms.agency
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