JAMA publication includes in-depth safety and
efficacy results from Vedanta’s successful Phase 2 study of
VE303
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company, noted today
that its Founded Entity, Vedanta Biosciences, a clinical-stage
company that is developing a potential new category of oral
therapies based on defined bacterial consortia, announced the
publication of Phase 2 study results from its lead program, VE303,
in the Journal of the American Medical Association (JAMA), as well
as a late-breaker oral presentation at the European Congress of
Clinical Microbiology in Infectious Diseases (ECCMID) annual
event.
The JAMA paper, “VE303, a Defined Bacterial Consortium, vs.
Placebo for the Prevention of Recurrent Clostridioides difficile
Infection: A Randomized Trial,” expands on the results of the Phase
2 study of VE303, which was designed to identify the recommended
dose for a Phase 3 study of VE303. The study data confirmed that
VE303 prevented recurrent Clostridioides difficile infection (CDI)
compared with placebo in the study population. The publication
announced today includes new analyses of secondary efficacy
endpoints, such as CDI recurrence rates at week 24, and stool
microbiome endpoints, which included both VE303 strain colonization
and gut microbiome diversity.
The ECCMID presentation offers more in-depth scrutiny of VE303
strain colonization dynamics and its relationship to the observed
clinical effect.
The full text of the announcement from Vedanta is as
follows:
Vedanta Biosciences Publishes Phase 2
Results in the Journal of the American Medical Association and
Presents at ECCMID
JAMA publication includes in-depth safety and
efficacy results from successful Phase 2 study of VE303
Additional analyses support a relationship
between VE303 exposure and clinical response via enhanced bacterial
colonization, in addition to new evidence of inflammation
modulation in treated patients
CAMBRIDGE, MA, April 17, 2023 – Vedanta Biosciences, a
clinical-stage company that is developing a potential new category
of oral therapies based on defined bacterial consortia, today
announced the publication of Phase 2 study results from its lead
program, VE303, in the Journal of the American Medical Association
(JAMA), as well as a late-breaker oral presentation at the European
Congress of Clinical Microbiology in Infectious Diseases (ECCMID)
annual event. The publication includes analyses of safety,
efficacy, in preventing recurrence of Clostridioides difficile
infection (rCDI), and VE303 strain colonization data from the
successfully completed Phase 2 study of VE303. The ECCMID
presentation offers more in-depth scrutiny of VE303 strain
colonization dynamics and its relationship to the observed clinical
effect. 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.
“First-generation microbiome approaches use fecal donor material
of variable composition, resulting in inconsistent efficacy
outcomes across different clinical studies. In contrast, the
results of our VE303 Phase 2 study demonstrate the potential
utility of reproducible product candidates that are based on
defined bacterial strains grown from clonal cell banks, in a manner
analogous to monoclonal antibody production,” said Jeffrey L.
Silber, M.D., Chief Medical Officer of Vedanta. “Our targeted
approach offers consistent composition and quality attributes,
which we believe could provide more consistent clinical benefit.
Defined bacterial consortia also avoid the risk of pathogen
transfer from donor stool—since there is no donor—and enable
greater scalability compared with fecal-derived approaches.”
“Vedanta’s VE303 candidate is based on compelling science that
illustrates the role of gut dysbiosis in persistent inflammatory
states and the potential for a rationally designed bacterial
consortium to restore that balance and support healthy homeostasis
of bacterial populations,” said Darrell Pardi, M.D., Chair of the
Division of Gastroenterology and Hepatology at the Mayo Clinic in
Rochester, Minnesota, and senior author of the JAMA paper. “The
notorious difficulty of preventing recurrent CDI creates a large
population of patients struggling with the condition, with few
therapeutic options. VE303 provides an approach that is designed to
address the underlying biology in a novel way. The clinical data
to-date have been extremely promising, and we are eager to see
future updates on this program as it progresses through the
clinic.”
The Journal of the American Medical Association
Publication
The JAMA paper, “VE303, a Defined Bacterial Consortium, vs.
Placebo for the Prevention of Recurrent Clostridioides difficile
Infection: A Randomized Trial,” expands on the results of the Phase
2 study of VE303, which was designed to identify the recommended
dose for a Phase 3 study of VE303. The study data confirmed that
VE303 prevented recurrent CDI compared with placebo in the study
population. The publication announced today includes new analyses
of secondary efficacy endpoints, such as CDI recurrence rates at
week 24, and stool microbiome endpoints, which included both VE303
strain colonization and gut microbiome diversity.
ECCMID Presentation
This presentation, titled, “An 8-strain defined bacterial
consortium promotes microbiota restoration and limits inflammation
in patients with recurrent Clostridioides difficile infection
(rCDI)” details how VE303 dosing was associated with reduced
inflammation within subjects at high risk of rCDI, determined by
biomarkers that included a reduction in fecal calprotectin levels
and changes in circulating serum cytokines. This analysis
demonstrates the possibility that VE303 may provide benefit beyond
microbiome restoration in patients with CDI, by limiting
pathological inflammation.
About VE303
VE303 is a 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 bypass the need to rely on direct
sourcing of 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 defined
bacterial consortium. Vedanta Biosciences received a $5.4 million
research grant from the Combating Antibiotic Resistant Bacteria
Biopharmaceutical Accelerator (CARB-X) in 2017 and a contract of up
to $81.9 million from Biomedical Advanced Research and Development
Authority (BARDA) 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 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 prevention of recurrent
C. difficile infection, inflammatory bowel diseases, food allergy,
and liver disease. These investigational therapies are grounded in
pioneering research by our scientific cofounders – 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 70 patents and has built what it believes is the
industry-leading platform for development of defined bacterial
consortia drugs. This platform includes one of the largest
libraries of bacteria derived from the human microbiome, vast
datasets from human interventional studies, proprietary
capabilities in consortium design, and end-to-end capabilities for
CGMP-compliant manufacturing of oral drug candidates spanning cell
banking, fermentation, lyophilization, and fill finish.
About Defined Bacterial Consortia
Defined Bacterial Consortia are assemblies of bacteria of
standardized composition that act cooperatively to exert a
therapeutic effect. The constituent strains in each consortium are
rationally selected from Vedanta’s extensive in-house strain
library, and grown from pure, clonal cell banks using scalable
fermentation processes. Each capsule contains precisely controlled
compositions and doses of the same live bacterial strains and is
formulated for stable oral delivery to the lower gastrointestinal
tract. We believe that our targeted approach offers consistent
composition and quality attributes, may provide more consistent
clinical benefit, limits safety risk, and enables greater
scalability compared with fecal-derived approaches.
About PureTech Health
PureTech is a biotherapeutics company dedicated to changing the
treatment paradigm for devastating diseases. 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 26 therapeutics and therapeutic
candidates, including two (Plenity® and EndeavorRx®) that have
received both U.S. FDA clearance and European marketing
authorization and a third (KarXT) that will soon be filed for FDA
approval, as of the most recent update by the Company. 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, including without limitation
those related to the Phase 2 study results of Vedanta’s VE303, the
potential therapeutic benefits of VE303, and Vedanta’s and
PureTech'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.
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