VE303 was well tolerated and decreased the odds
of rCDI through multiple mechanisms
Analyses identified predictors of VE303
colonization and protection from CDI recurrence
Topline data for the ongoing Phase 3 pivotal
RESTORATiVE303 study are expected in 2026
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
changing the lives of patients with devastating diseases, noted
that its Founded Entity, Vedanta Biosciences, a late clinical-stage
company developing defined bacterial consortia as oral therapies
for gastrointestinal diseases, today announced the publication of
additional results from the Phase 2 CONSORTIUM study for its lead
candidate, VE303, which is being evaluated for prevention of
recurrent Clostridioides difficile infection (rCDI). The new
analyses were published this month in Nature Medicine and can be
viewed online.
VE303 is a potential first-in-class Live Biotherapeutic Product
for the prevention of rCDI, which consists of a defined consortium
of eight bacterial strains. Clinical results from Vedanta’s
successful Phase 2 CONSORTIUM study, published in the Journal of
the American Medical Association (JAMA), demonstrated that the
higher dose of VE303 studied was well tolerated and reduced the
odds of CDI recurrence by more than 80% compared with placebo.
The new publication which is entitled “Multi-omic Profiling a
Defined Bacterial Consortium for Treatment of Recurrent
Clostridioides difficile Infection,” reports additional results
from CONSORTIUM. Profiling of microbiome composition, fecal
metabolites, and host immune function indicated that VE303 works
through multiple mechanisms to prevent rCDI by restoring a healthy
gut microbial community, decreasing inflammation, and increasing
levels of protective metabolites. In addition, the work identified
predictors of high or low VE303 colonization and clinical
response.
Taken together, these results demonstrate that VE303 works
through multiple mechanisms to reduce CDI recurrence. Results from
the CONSORTIUM study informed the design and dose selection for the
global, pivotal Phase 3 study, RESTORATiVE303, that is currently
underway to confirm the efficacy and safety profile of VE303 in the
prevention of rCDI. Topline data for this study are expected in
2026.
The full text of the announcement from Vedanta is as
follows:
Vedanta Biosciences Publishes Additional
Phase 2 VE303 Results in Nature Medicine
VE303 was well tolerated and decreased the odds
of rCDI through multiple mechanisms
Analyses identified predictors of VE303
colonization and protection from CDI recurrence
Topline data for the ongoing Phase 3 pivotal
RESTORATiVE303 study are expected in 2026
CAMBRIDGE, Mass., January 23, 2025 -- Vedanta Biosciences, a
late clinical-stage company developing defined bacterial consortia
as oral therapies for gastrointestinal diseases, today announced
the publication of additional results from the Phase 2 CONSORTIUM
study for its lead candidate, VE303, which is being evaluated for
prevention of recurrent Clostridioides difficile infection (rCDI).
The new analyses were published this month in Nature Medicine and
can be viewed online.
VE303 is a potential first-in-class Live Biotherapeutic Product
for the prevention of rCDI, which consists of a defined consortium
of eight bacterial strains. Clinical results from Vedanta’s
successful Phase 2 CONSORTIUM study, published in the Journal of
the American Medical Association (JAMA), demonstrated that the
higher dose of VE303 studied was well tolerated and reduced the
odds of CDI recurrence by more than 80% compared with placebo.
VE303 organisms rapidly and robustly colonize the gut in a
dose-dependent manner. Colonization predicted greater
recurrence-free probability, establishing a direct connection
between exposure and clinical response.
The publication which is entitled “Multi-omic Profiling a
Defined Bacterial Consortium for Treatment of Recurrent
Clostridioides difficile Infection,” reports additional results
from CONSORTIUM. Profiling of microbiome composition, fecal
metabolites, and host immune function indicated that VE303 works
through multiple mechanisms to prevent rCDI by restoring a healthy
gut microbial community, decreasing inflammation, and increasing
levels of protective metabolites. In addition, the work identified
predictors of high or low VE303 colonization and clinical
response.
“This clinical research offers new insights into the mechanisms
of action of VE303, providing a rationale for the drug’s protective
effects in rCDI,” said Bernat Olle, Ph.D., Chief Executive Officer
of Vedanta Biosciences. “Due to VE303’s precisely known, defined
composition, we can study its mechanisms of action and PK-PD
relationships in a rigorous way, taking a step towards
understanding why some patients respond better than others to a
microbiome restoration intervention. We believe this line of work
helps fill a knowledge gap in the field, since characterization of
the mechanisms of action of first-generation fecal microbiota
products has been very limited.”
Highlights of the publication include:
- Abundance of specific VE303 strains, and of VE303 strains
overall, was predictive of remaining recurrence-free.
- The strains that colonized well differed across individuals,
suggesting that efficacy is derived from strains working together
as a consortium.
- VE303 colonization and clinical benefit correlated with
increased levels of short-chain fatty acids and key secondary bile
acids, both of which have beneficial effects in conferring
resistance to CDI.
- Faster recovery of a more diverse microbiome, which was seen in
the high dose recipients of VE303, was associated with
non-recurrence.
- The elimination rate of the antibiotic used for the CDI episode
was a predictor of VE303 colonization. Given that clearance of
residual antibiotic from stool varies significantly among
individuals and can take a week or longer, treating with VE303 for
14 consecutive days following completion of standard-of-care
antibiotics enabled VE303 strains to be inoculated when the
intestinal environment was most permissive to colonization.
- VE303 use led to lower levels of pro-inflammatory and
potentially pathogenic Gram-negative species, including Klebsiella
and Citrobacter, that are linked to CDI recurrence and AMR
bacterial infections.
Taken together, these results demonstrate that VE303 works
through multiple mechanisms to reduce CDI recurrence. Results from
the CONSORTIUM study informed the design and dose selection for the
global, pivotal Phase 3 study, RESTORATiVE303, that is currently
underway to confirm the efficacy and safety profile of VE303 in the
prevention of rCDI. Topline data for this study are expected in
2026.
This project has been supported in whole or in part with federal
funds from the Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority (BARDA), under contract
number 75A50120C00177.
About VE303
VE303 is a potential first-in-class Live Biotherapeutic Product
for the prevention of recurrent Clostridioides difficile infection
(rCDI). VE303 is an orally administered, defined bacterial
consortium therapeutic candidate which consists of eight strains
that were rationally selected using Vedanta’s product 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 published positive results in JAMA in April
2023 from the Phase 2 CONSORTIUM trial, in which VE303 met its
primary endpoint of preventing C. difficile infection recurrence at
eight weeks. Vedanta is currently enrolling patients into a Phase 3
RESTORATiVE303 registrational study of VE303 for the prevention of
recurrent C. difficile infection. 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 a clinical-stage biopharmaceutical
company developing medicines for the treatment of gastrointestinal
diseases. The company’s lead assets are potential first-in-class
oral therapies – VE303, in a Phase 3 registrational trial for
prevention of recurrent C. difficile infection, and VE202, in a
Phase 2 trial for treatment of ulcerative colitis. Vedanta’s
pipeline has been built using the company’s industry-leading
product engine for the development of therapies based on defined
consortia of bacteria grown from pure clonal cell banks. The
product engine, supported by broad foundational intellectual
property, includes one of the largest libraries of bacteria
isolated from the human microbiome, vast clinical datasets,
proprietary capabilities in consortium design, and end-to-end CGMP
manufacturing capabilities at commercial launch scale.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to giving life to new classes of medicine to change the lives of
patients with devastating diseases. The Company has created a broad
and deep pipeline through its experienced research and development
team and its extensive network of scientists, clinicians and
industry leaders that is being advanced both internally and through
its Founded Entities. PureTech's R&D engine has resulted in the
development of 29 therapeutics and therapeutic candidates,
including three that have been approved by the U.S. Food and Drug
Administration. A number of these programs are being advanced by
PureTech or its Founded Entities in various indications and stages
of clinical development, including registration enabling studies.
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.
For more information, visit www.puretechhealth.com or connect
with us on X (formerly Twitter) @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be
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 those related to Vedanta’s development plans for
its pipeline of therapeutics of defined bacterial consortia as oral
therapies for gastrointestinal diseases, including VE303, the
timing of topline results for ongoing clinical trials, potential
benefits to patients, and Vedanta’s and our future prospects,
developments 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, 2023, 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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