Full Phase 1 data analysis of VE303, a defined
bacterial consortium candidate for C. difficile infection,
published in Cell Host & Microbe
Positive topline Phase 2 results for VE303
announced in 2021; Phase 3 preparations underway
Acceptance of three abstracts for podium
presentations at Digestive Disease Week 2022
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company noted that its
Founded Entity, Vedanta Biosciences (“Vedanta”), today announced
the publication in the journal Cell Host & Microbe of the
results from a Phase 1a/1b study evaluating the safety,
tolerability, and colonization dynamics of VE303 in healthy adults.
VE303 is a potential first-in-class defined bacterial consortium
candidate for the prevention of recurrent Clostridium difficile
infection (CDI). Vedanta will also share three research updates
across its VE303 and VE202 (for inflammatory bowel disease)
programs in podium presentations at Digestive Disease Week in May
2022.
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.
The Cell Host & Microbe paper, “Colonization of the Live
Biotherapeutic Product VE303 and Modulation of the Microbiota and
Metabolites in Healthy Volunteers,” details the results of a
first-in-human Phase 1a/1b dose-escalation study of VE303 in
healthy adults. VE303 was observed to be generally well-tolerated
at all doses tested and to colonize optimally if dosed over
multiple days after vancomycin pretreatment. The work illuminates
some fundamental features of the colonization dynamics of a live
biotherapeutic product (LBP) that may be generalizable.
Specifically, it shows that the proportion of LBP strains that
colonize, as well as the abundance and durability of colonization,
can be significantly improved by the use of a higher dose, longer
duration of dosing, and pretreatment with a short course of
antibiotics to create an ecological niche for engraftment. VE303
colonization was associated with earlier and increased
concentrations of secondary bile acids and short-chain fatty acids,
and promoted the establishment of a microbiota community known to
resist enteric pathogen colonization.
Vedanta will present three abstracts at Digestive Disease Week
(DDW) 2022, held virtually and in person in San Diego, California,
from May 21-24, 2022. Two of the abstracts are focused on VE303
Phase 2 topline results in CDI and one abstract is focused on
VE202, a defined bacterial consortium candidate being developed as
an oral treatment for inflammatory bowel disease.
The full text of the announcement from Vedanta is as
follows:
Vedanta Biosciences Publishes Phase 1a/1b
Results for Lead Program VE303 in Cell Host & Microbe and
Highlights Planned Presentations of Phase 2 VE303 Results
Full Phase 1 data analysis of VE303, a defined
bacterial consortium candidate for C. difficile infection,
published in Cell Host & Microbe
Positive topline Phase 2 results for VE303
announced in 2021; Phase 3 preparations underway
Acceptance of three abstracts for podium
presentations at Digestive Disease Week 2022
CAMBRIDGE, MA, April 13, 2022 – Vedanta Biosciences, a
leading clinical-stage company developing a potential new category
of oral therapies based on defined bacterial consortia, today
announced the publication in the journal Cell Host & Microbe of
the results from a Phase 1a/1b study evaluating the safety,
tolerability, and colonization dynamics of VE303 in healthy adults.
VE303 is a potential first-in-class defined bacterial consortium
candidate for the prevention of recurrent Clostridium difficile
infection (CDI). The company will also share three research updates
across its VE303 and VE202 (for inflammatory bowel disease)
programs in podium presentations at Digestive Disease Week in May
2022.
“In this publication of our Phase 1 results, we show that we
were able to precisely quantify the colonization dynamics of
microbiome-directed agents based on defined bacterial consortia,
such as VE303, and identify key factors that drive better
colonization,” said Bernat Olle, Ph.D., Co-Founder and Chief
Executive Officer of Vedanta Biosciences. Colonization dynamics are
analogous to traditional drug pharmacokinetics and refer to the
growth and persistence over time of bacterial strain populations in
the human gut.
“This allows us to quantitatively describe the relationship
between drug exposure and effect, which may enable optimized
treatment regimens and rational analysis of clinical data. This
predictability is missing from older approaches that rely on human
donors, as the dose and identity of bacterial species vary widely
with each fecal donation,” continued Dr. Olle. “In our subsequent
Phase 2 study of VE303 in CDI, we showed that better colonization
correlates with greater likelihood of sustained clinical cure.
Together, we believe these results offer a more rational path
forward for clinical development of microbiome-directed
medicines.”
Phase 1a/1b study results The Cell Host & Microbe
paper, “Colonization of the Live Biotherapeutic Product VE303 and
Modulation of the Microbiota and Metabolites in Healthy
Volunteers,” details the results of a first-in-human Phase 1a/1b
dose-escalation study of VE303 in healthy adults. VE303 was
observed to be generally well-tolerated at all doses tested and to
colonize optimally if dosed over multiple days after vancomycin
pretreatment. The work illuminates some fundamental features of the
colonization dynamics of a live biotherapeutic product (LBP) that
may be generalizable. Specifically, it shows that the proportion of
LBP strains that colonize, as well as the abundance and durability
of colonization, can be significantly improved by the use of a
higher dose, longer duration of dosing, and pretreatment with a
short course of antibiotics to create an ecological niche for
engraftment. VE303 colonization was associated with earlier and
increased concentrations of secondary bile acids and short-chain
fatty acids, and promoted the establishment of a microbiota
community known to resist enteric pathogen colonization.
Digestive Disease Week 2022 abstract acceptances
Vedanta will present three abstracts at Digestive Disease Week
(DDW) 2022, held virtually and in person in San Diego, California,
from May 21-24, 2022. Two of the abstracts are focused on VE303
Phase 2 topline results in CDI and one abstract is focused on
VE202, a defined bacterial consortium candidate being developed as
an oral treatment for inflammatory bowel disease.
Details of the presentations are as follows:
Abstract 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 of the phase 2 CONSORTIUM study
Presenter: Thomas Louie, M.D. Session Type:
Research Forum Session Title: Mechanisms and Efficacy
of Microbial Therapeutics in Infectious and Functional GI
Diseases Session Date and Time: May 21, 2022, from
10:00 a.m. to 11:30 a.m. PDT Presentation Time: 11:00
a.m. PDT
Abstract Title: Durable colonization of the rationally
designed live biotherapeutic products VE202 and VE818 in healthy
volunteers Presenter: Emily Crossette, Ph.D.
Session Type: Research Forum Session Title: The
Role of the Microbiome in IBD Session Date and Time:
May 22, 2022, from 2:00 p.m. to 3:30 p.m. PDT Presentation
Time: 3:15 p.m. PDT
Abstract 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: Rajita Menon, Ph.D. Session
Type: Research Forum Session Title: Diagnostic and
Therapeutic implications of Gut Microbiome in Diarrheal Disorders
including C. difficile Infection Session Date and
Time: May 24, 2022, from 8:00 a.m. to 9:30 a.m. PDT
Presentation Time: 8:15 a.m. PDT
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
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 grant from the
Combating Antibiotic Resistant Bacteria Biopharmaceutical
Accelerator (CARB-X) in 2017 and a contract of up to $76.9 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 VE202 VE202 is a first-in-class, orally
administered, 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, oncology, liver disease, and food
allergy. 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 to be the world’s biggest library 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 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 Vedanta’s modern
understanding of the cross-talk between the microbiome and the
immune system.
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 25
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
Half Year 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 the Company's unique insights into the biology of the
brain, immune and gut, or BIG, systems and the interface between
those systems, referred to as the BIG Axis.
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, 2020 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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