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RNS Number : 9582J
4d Pharma PLC
17 April 2020
Interim analysis of Blautix phase II study data
Indicates encouraging safety profile and non-futility of
study
Leeds, UK, April 17, 2020 - 4D pharma plc (AIM: DDDD), a
pharmaceutical company leading the development of Live
Biotherapeutics, today announces the key findings of a planned
interim analysis in its BHT-II-0002 study in IBS.
BHT-II-0002 is 4D Pharma's phase II, randomized, double blind,
placebo-controlled, multicentre study. It is evaluating the safety
and efficacy of repeated oral doses of the company's Live
Biotherapeutic, Blautix, in adult subjects with irritable bowel
syndrome (IBS) subtypes IBS-C and IBS-D.
The BHT-II-0002 study interim analysis, aimed to support
clinical and commercial development plans, has been conducted on a
total of 246 IBS patients (118 IBS-C and 128 IBS-D). Data on around
78 additional patients who have all finished drug treatment and
primary endpoint evaluations for all patients are expected to be
included in the full study analysis and trial data. 4D Pharma
expects to report on this full data set as planned in Q3 2020.
The interim analysis demonstrates that Blautix has a safety
profile comparable to placebo, with 3% vs 2% patient
discontinuation in the drug group vs. placebo due to adverse events
(AE). There was one recorded severe adverse event (SAE) in each arm
with no relation to study drug, and mild or moderate adverse events
reported in 24% of subjects for both Blautix and placebo arms,
indicating that the treatment has no increased adverse effects
compared to placebo. The interim analysis of the primary endpoint
of the IBS study (described more fully below) shows that the study
is not futile and 4D pharma plc is encouraged to continue the
analysis of the full trial data.
"The interim analysis of the Blautix phase II results in IBS is
encouraging," says Dr. Alex Stevenson, Chief Scientific Officer, 4D
Pharma. "IBS is a disease that causes significant morbidity and has
a high unmet medical need. 4D Pharma identified the potential of
the live biotherapeutic Blautix as a new approach to treat IBS and
address both IBS-C and IBS-D with the same therapy. The interim
analysis supports and informs 4D Pharma's future development and
commercialisation plans with partners."
About Blautix
Blautix is a single strain live biotherapeutic product, being
developed as a single 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 could increase
microbiome diversity and stability in IBS patients. An improvement
in symptoms was also reported relative to placebo. Further
information on the phase II study can be found below and at
ClinicalTrials.gov Identifier: NCT03721107 .
About IBS
IBS has an incidence of 11% internationally, ranging from 10% to
25% in different regions. Around 30% of people who experience the
symptoms of IBS will consult physicians for their IBS symptoms. IBS
has different subtypes, IBS-C, IBS-D and IBS-M, which comprise in
the US 38.5%, 32.5% and 29.0% of diagnosed cases respectively.
Existing approved treatments are focused on addressing the specific
symptoms of disease subtypes, rather than the underlying disease
and often have significant side effects and modest levels of
efficacy. Research indicates that the microbiome is altered in IBS
patients compared to healthy controls, but that the alteration is
consistent across the different sub-types, suggesting the
possibility that a microbiome based intervention could address
multiple subtypes.
About the BHT-II-0002 study
This study has recruited over 300 patients in 35 investigator
sites in the USA and the UK. The interim analysis included
evaluation of the primary endpoint of the study, which is based on
the number of overall responders in each group.The definition of an
overall responder is IBS subtype specific and consists of two
components. For both IBS subtypes, the first component is the
weekly average of abdominal pain intensity. Improvement is defined
as a decrease of at least 30% compared with baseline. The second
component is different for the two IBS subtypes and relates to
stool frequency per week for IBS-C and a reduction in incidence of
loose stool consistency for IBS-D compared with baseline. In order
for a subject to be classed as a responder, both components must
show improvement in the same week for at least 50% of the treatment
period of 8 weeks.
About 4D
Founded in February 2014, 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's Live Biotherapeutic Products are orally delivered single
strains of bacteria that are naturally found in the healthy human
gut. The Company has five clinical studies in progress, namely a
Phase II clinical study of BLAUTIX(R) in Irritable Bowel Syndrome
(IBS), a Phase I/II study of MRx0518 in combination with
KEYTRUDA(R) (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 and a
Phase I/II study of MRx-4DP0004 in asthma. 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 .
Contact Information:
4D
Duncan Peyton, Chief Executive Officer + 44 (0)113 895 0130
Investor Relations ir@4dpharmaplc.com
N+1 Singer - Nominated Adviser and Joint Broker +44 (0) 20 7496
3000
Aubrey Powell / Justin McKeegan / Alex Bond (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332
2500
Dominic Wilson / Phil Walker
Image Box PR
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
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