TIDMPRTC
PureTech Health PLC
24 May 2022
24 May 2022
PureTech Health plc
PureTech Founded Entity Vedanta Biosciences Presents Data from
Multiple Studies at Digestive Disease Week 2022 Annual Meeting
Data presentations include review of the VE303 Phase 2
CONSORTIUM study, in which VE303 was well tolerated and highly
active at preventing Clostridioides difficile infection recurrence
in subjects at high risk of recurrence
Further CONSORTIUM study analysis shows that the VE303 high dose
led to more robust colonization, which in turn correlated with
prevention of recurrence
Safety and colonization analyses of VE202 and VE818 Phase 1
studies show they were well tolerated, colonized robustly after
vancomycin pretreatment, and were associated with increased
production of secondary bile acids that are known to induce immune
tolerance
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company noted that its
Founded Entity, Vedanta Biosciences, Inc. ("Vedanta"), today
announced the details of three podium presentations of research
informed by multiple clinical studies at Digestive Disease Week
(DDW) 2022, being held both virtually and in person in San Diego,
CA on May 21-24. The analyses cover several defined bacterial
consortia candidates developed by Vedanta, and include assessments
of safety, tolerability, efficacy, and the relationships between
dosing regimen, consortium strain colonization, and restoration of
a patient's resident microbial community. These analyses further
deepen Vedanta's understanding of the clinical pharmacology and
potential benefits of defined bacterial consortia, and help inform
future clinical research. This body of data builds on published
analyses from earlier clinical work that identified key factors
that drive colonization of Vedanta's candidates.
The full text of the announcement from Vedanta is as
follows:
Vedanta Presents Data from Multiple Studies at Digestive Disease
Week 2022 Annual Meeting
Data presentations include review of the VE303 Phase 2
CONSORTIUM study, in which VE303 was well tolerated and highly
active at preventing Clostridioides difficile infection recurrence
in subjects at high risk of recurrence
Further CONSORTIUM study analysis shows that the VE303 high dose
led to more robust colonization, which in turn correlated with
prevention of recurrence
Safety and colonization analyses of VE202 and VE818 Phase 1
studies show they were well tolerated, colonized robustly after
vancomycin pretreatment, and were associated with increased
production of secondary bile acids that are known to induce immune
tolerance
CAMBRIDGE, MA - Vedanta Biosciences , a clinical-stage
biopharmaceutical company pioneering the development of oral
therapies based on defined bacterial consortia, today announced the
details of three podium presentations of research informed by
multiple clinical studies at Digestive Disease Week (DDW) 2022,
being held both virtually and in person in San Diego, CA on May
21-24. The analyses cover several defined bacterial consortia
candidates developed by Vedanta, and include assessments of safety,
tolerability, efficacy, and the relationships between dosing
regimen, consortium strain colonization, and restoration of a
patient's resident microbial community. These analyses further
deepen Vedanta's understanding of the clinical pharmacology and
potential benefits of defined bacterial consortia and help inform
future clinical research. This body of data builds on published
analyses from earlier clinical work that identified key factors
that drive colonization of Vedanta's candidates.
"As leaders in the research and development of defined bacterial
consortia-based therapies, we are continually pushing to deepen our
ability to understand and shape clinical outcomes by quantifying
the colonization dynamics of our rationally designed and rigorously
manufactured product candidates. This effort is part of our work to
overcome the limitations of older methods, such as fecal matter
transplants and spore fractions, which are inherently variable,
challenging to scale, and susceptible to pathogen transmission from
donors," said Jeffrey Silber, M.D., Chief Medical Officer of
Vedanta Biosciences. "These analyses from three different clinical
programs provide substantial further elucidation of the factors
that affect the behavior and clinical impact of defined bacterial
consortia in patients. As we prepare for our first Phase 3 clinical
trial, for VE303, we are drawing upon a comprehensive body of
knowledge to shape our clinical strategy."
Colonization dynamics is analogous to traditional drug
pharmacokinetics and refers to the growth and persistence over time
of bacterial strain populations in the human gut.
Details of the Oral Presentations at DDW 2022:
Title: An 8-strain, rationally defined bacterial consortium,
VE303, reduces the risk of Clostridioides difficile infection (CDI)
recurrence compared with placebo in adults at high risk for
recurrence: Results for the Phase 2 CONSORTIUM study
Presenter: Thomas Louie, M.D.
The design and topline results of this study were announced in
October 2021, which formed the basis for this presentation.
Overall, in the CONSORTIUM study, VE303 was well tolerated and
highly active at preventing CDI recurrence in subjects at high risk
of recurrence.
The VE303 high dose met the primary endpoint of a lower
recurrence rate at eight weeks, when compared with placebo (13.8
percent versus 45.5 percent). This 31.7 percent reduction in
absolute risk of recurrence reflected a greater than 80 percent
reduction in the odds of a recurrence in the VE303 high-dose group
compared with the placebo group (odds ratio 0.192; 90 percent
confidence interval 0.048, 0.712; p=0.0077). Most patients in the
study reported one or more adverse events, but the overall safety
profiles were similar across the active and placebo groups, and
most adverse events were of mild intensity. There were no
treatment-related serious adverse events in any group.
Title: Rapid and durable colonization of VE303 in Clostridioides
difficile infection (CDI) patients is associated with clinical
efficacy: Results of the Phase 2 CONSORTIUM study
Presenter and time : Rajita Menon, Ph.D.
This analysis evaluated fecal samples from study participants in
the Phase 2 CONSORTIUM study that were obtained during dosing and
at weeks four and seven. Metagenomic sequencing was performed to
identify associations between VE303 strain colonization, resident
microbes, and clinical safety and efficacy endpoints.
Among the enrolled patients who were at high risk of CDI
recurrence, the VE303 high dose led to more robust colonization of
the eight consortium strains at Day 14 than the VE303 low dose, in
terms of both strain detection (median, six versus three strains)
and relative abundance (median, 5.2 percent versus 0.8 percent).
Better VE303 strain colonization was associated with clinical
activity and was greatest among those who received the VE303 high
dose. Across all VE303 recipients, higher colonization at the end
of dosing was associated with a lower probability of CDI
recurrence. Higher bacterial species diversity and more rapid
recovery of the normal resident microbial community were observed
with use of VE303 high dose and were also associated with
non-recurrence.
Title : Durable colonization of the rationally designed live
biotherapeutic products VE202 and VE818 in healthy volunteers.
Presenter: Emily Crossette, Ph.D.
The Phase 1 studies of VE202 (a defined bacterial consortium
candidate for inflammatory bowel disease) and VE818 (a defined
bacterial consortium candidate for an undisclosed indication) were
similarly designed double-blind, placebo-controlled studies in
healthy adults, enrolling a total of 31 and 74 subjects,
respectively. The studies assessed safety, tolerability, and
colonization dynamics. Subjects received a low dose, high dose, or
placebo for one or 14 days, with or without vancomycin antibiotic
pretreatment, and were followed for six months after treatment.
Strain colonization was quantified with metagenomics and
quantitative polymerase chain reaction (qPCR). Additionally, levels
of bacterial metabolites associated with immune tolerance were
measured.
Both VE202 and VE818 were well tolerated. Vancomycin
pretreatment was required to ensure robust strain colonization.
Strain colonization was persistent in most subjects through the
end-of-study visit. Additionally, dose duration was an important
driver of long-term persistence of colonization. Colonization with
VE202 and VE818 was associated with increased stool concentrations
of secondary bile acids, which have several beneficial
immunoregulatory functions, as early as the first week of
treatment.
About VE303
VE303 is a first-in-class defined bacterial consortium
therapeutic candidate designed for the prevention of recurrent
Clostridioides difficile infection (rCDI). It consists of eight
strains that were rationally selected using Vedanta's discovery
engine. VE303 is produced from pure, clonal bacterial cell banks,
which yield a standardized drug product in powdered form and
bypasses the need to rely on direct sourcing from donor fecal
material of inconsistent composition. Vedanta reported positive
topline results in October 2021 from the Phase 2 CONSORTIUM trial,
in which VE303 was associated with a 31.7% absolute risk reduction
in the rate of recurrence when compared with placebo, representing
a greater than 80% reduction in the odds of a CDI recurrence.
Vedanta believes VE303 has the potential to become a first-in-class
therapeutic based on a rationally defined bacterial consortium.
Vedanta Biosciences received a $5.4 million research award from the
Combating Antibiotic-Resistant Bacteria Biopharmaceutical
Accelerator (CARB-X) in 2017 and a contract of up to $76.9 million
from the Biomedical Advanced Research and Development Authority
(contract number 75A50120C00177) within the U.S. Department of
Health and Human Services' Office of the Assistant Secretary
for
Preparedness and Response in 2020 to support clinical studies of
VE303. VE303 was granted Orphan Drug Designation in 2017 by the
U.S. Food and Drug Administration (FDA) for the prevention of
recurrent CDI.
About VE202
VE202 is a first-in-class defined bacterial consortium
therapeutic candidate for the treatment of inflammatory bowel
disease (IBD). It consists of 16 bacterial strains of the
Clostridia class that were rationally selected. It is designed to
induce immune tolerance in the gut, reverse the gut microbiota
abnormalities that are common in patients with IBD, and strengthen
the epithelial barrier. Results describing the biology and
candidate selection of VE202 were previously described in multiple
publications in Science and Nature. In a Phase 1 study conducted in
healthy adults, VE202 colonized abundantly following a short course
of antibiotic pretreatment, with most strains detected in stool
samples from most study participants within 1 week and persisting
through the final sample at Week 24. Multiple-day dosing led to
significantly greater and more durable colonization than did
single-day dosing. VE202 was also well tolerated, with most adverse
events unrelated to study treatment, gastrointestinal in nature,
and of mild or moderate intensity.
About Vedanta Biosciences
Vedanta Biosciences is leading the development of a potential
new category of oral therapies based on defined consortia of
bacteria isolated from the human microbiome and grown from pure
clonal cell banks. The company's clinical-stage pipeline includes
product candidates being evaluated for the treatment of high-risk
C. difficile infection, inflammatory bowel diseases, food allergy,
liver disease, and cancer. These investigational therapies are
grounded in pioneering research - published in leading journals
including Science , Nature , and Cell - to identify beneficial
bacteria that live symbiotically within the healthy human gut,
fight pathogens and induce a range of potent immune responses.
Vedanta Biosciences controls a foundational portfolio of more than
45 patents and has built what it believes is one of the largest
libraries of bacteria derived from the human microbiome.
Proprietary capabilities include deep expertise in consortium
design, vast datasets from human interventional studies, and
CGMP-compliant manufacturing of oral Live Biotherapeutic Product
(LBP) candidates containing pure, clonally-derived bacterial
consortia in powdered form. Vedanta Biosciences was founded by
PureTech Health ( Nasdaq: PRTC, LSE: PRTC) and a global team of
scientific co-founders who pioneered the modern understanding of
the cross-talk between the microbiome and the immune system.
About Digestive Disease Week (R)
Digestive Disease Week(R) (DDW) is the largest international
gathering of physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW is an in-person and virtual
meeting from May 21-24, 2022. The meeting showcases more than 3,100
abstracts and hundreds of lectures on the latest advances in GI
research, medicine and technology. More information can be found at
www.ddw.org .
Acknowledgement and Disclaimer :
Vedanta's VE303 program has been funded in part with Federal
funds from the Department of Health and Human Services; Office of
the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract
No.75A5012C00177.
The VE303 research reported in this press release is supported
in part by CARB-X. CARB-X's funding for this project is sponsored
by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and
by an award from Wellcome. The content is solely the responsibility
of the authors and does not necessarily represent the official
views of CARB-X or any of its funders.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, among others. The Company has
created a broad and deep pipeline through the expertise of its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders.
This pipeline, which is being advanced both internally and
through PureTech's Founded Entities, is comprised of 27
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization, as of the date of PureTech's most recently filed
Annual Report and corresponding Form 6-K. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and
then advanced by the PureTech team through key validation points
based on unique insights in immunology and drug development.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
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the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
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that relate to Vedanta's future prospects, development plans, and
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PureTech
Public Relations
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IR@puretechhealth.com
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