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® Digestive Disease
Week® (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 This
press release contains forward-looking statements within 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 forward-looking
statements, including without limitation statements that relate to
Vedanta’s future prospects, development plans, and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks, uncertainties and other
important factors that could cause actual results, performance and
achievements to differ materially from current expectations,
including, but not limited to, those risks, uncertainties and other
important factors described under the caption “Risk Factors” in our
Annual Report on Form 20-F for the year ended December 31, 2021
filed with the SEC and in our other regulatory filings. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the Company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements, we
disclaim any obligation to update or revise these forward-looking
statements, whether as a result of new information, future events
or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220524005490/en/
PureTech Public Relations
publicrelations@puretechhealth.com Investor Relations
IR@puretechhealth.com
EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
PureTech Health (NASDAQ:PRTC)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
PureTech Health (NASDAQ:PRTC)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024