High-dose VE303 in Phase 2 trial achieved
primary endpoint, with 31.7% absolute risk reduction in rate of
recurrence (or a greater than 80% reduction in the odds of a
recurrence) at 8 weeks when compared with placebo
Represents most advanced clinical trial of a
rationally defined bacterial consortium candidate
BARDA
exercises $23.8 million option to support Phase 3 clinical trial of
VE303, to initiate in 2022
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company, is pleased to
note that its Founded Entity, Vedanta Biosciences (“Vedanta”) today
announced that its Phase 2 clinical trial of VE303, an orally
administered investigational live biotherapeutic product in
development for the prevention of recurrent C. difficile infection
(CDI) in high-risk patients, met its primary endpoint of preventing
disease recurrence through Week 8. VE303 achieved a 31.7 percent
absolute risk reduction in rate of recurrence when compared with
placebo, representing a greater than 80 percent reduction in the
odds of a recurrence. This is the most advanced clinical trial of
an investigational drug based on a rationally defined bacterial
consortium, a microbiome-based therapeutic approach that delivers
orally administered candidates of precisely known composition that
can be manufactured with pharmaceutical-grade consistency.
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PureTech Founded Entity, Vedanta
Biosciences, announced today that its Phase 2 clinical trial of
VE303, an orally administered investigational live biotherapeutic
product in development for the prevention of recurrent C. difficile
infection (#CDI) in high-risk patients, met its primary endpoint of
preventing disease recurrence through Week 8. VE303 achieved a
31.7% absolute risk reduction in rate of recurrence when compared
with placebo, representing a greater than 80% reduction in the odds
of a recurrence. (Photo: Business Wire)
Based on the Phase 2 data, the Biomedical Advanced Research and
Development Authority (BARDA) has exercised its first contract
option for additional funding of $23.8 million, pursuant to its
existing 2020 contract with Vedanta, to support the Phase 3
clinical trial of VE303, which Vedanta plans to initiate in
2022.
The full text of the announcement from Vedanta is as
follows:
Vedanta Announces Positive Topline Phase 2
Data for VE303 in High-Risk C. difficile Infection and Exercise of
$23.8 Million Option by BARDA
High-dose VE303 in Phase 2 trial achieved
primary endpoint, with 31.7% absolute risk reduction in rate of
recurrence (or a greater than 80% reduction in the odds of a
recurrence) at 8 weeks when compared with placebo
Represents most advanced clinical trial of a
rationally defined bacterial consortium candidate
BARDA
exercises $23.8 million option to support Phase 3 clinical trial of
VE303, to initiate in 2022
CAMBRIDGE, MA – Vedanta Biosciences, a clinical-stage
company that is developing a potential new category of oral
therapies based on defined bacterial consortia, today announced
that its Phase 2 clinical trial of VE303, an orally administered
investigational live biotherapeutic product in development for the
prevention of recurrent C. difficile infection (CDI) in high-risk
patients, met its primary endpoint of preventing disease recurrence
through Week 8.
VE303 achieved a 31.7 percent absolute risk reduction in rate of
recurrence when compared with placebo, representing a greater than
80 percent reduction in the odds of a recurrence. This is the most
advanced clinical trial of an investigational drug based on a
rationally defined bacterial consortium, a microbiome-based
therapeutic approach that delivers orally administered candidates
of precisely known composition that can be manufactured with
pharmaceutical-grade consistency.
The positive results of the Phase 2 study triggered a $23.8
million contract option from the Biomedical Advanced Research and
Development Authority (BARDA), part of the HHS Office of the
Assistant Secretary for Preparedness and Response, to support a
Phase 3 clinical trial of VE303, which Vedanta plans to initiate in
2022.
“We believe these results are an important step forward for the
prevention of C. difficile infection and the microbiome field at
large. These data substantially add to the evidence in support of a
therapeutic approach that bypasses the use of fecal donations or
their spore fractions. Those first-generation approaches have shown
variability in outcomes across studies, potential for transmission
of infectious agents, and have significant challenges in
scalability for serving large populations,” said Bernat Olle,
Ph.D., Chief Executive Officer of Vedanta Biosciences. “From our
inception, Vedanta has focused on delivering advances that will
enable us to rationally design and manufacture – at scale –
therapeutics based on defined bacterial consortia, which we believe
can address the limitations of earlier approaches and potentially
be broadly applicable across a range of diseases.”
Recurrent CDI causes approximately half a million infections
each year in the United States, including up to 165,000 recurring
infections and up to 45,000 deaths. Existing treatments include
antibiotics, which can further damage the gut microbiome. This can
leave patients vulnerable to both CDI recurrence and infection by a
variety of other bacterial species, which could encourage the
spread of antibiotic resistance. VE303 is a potential new tool
against CDI that is designed to reconstitute a patient’s gut
microbiome while supporting better antibiotic stewardship in the
healthcare system.
Summary and topline data from the Phase 2 CONSORTIUM
trial
The Phase 2 CONSORTIUM trial was a randomized, double-blind,
placebo-controlled trial designed to evaluate the safety and
efficacy of VE303 to treat patients at high risk of recurrent CDI.
The trial enrolled 79 patients who had completed a successful
course of treatment with standard-of-care antibiotics for recurrent
CDI or for a primary CDI episode with one or more characteristics
that placed those patients at high risk of recurrence.
The trial evaluated low-dose VE303, high-dose VE303 (the active
treatment groups), and placebo. Following completion of their
standard-of-care antibiotic treatment for CDI, trial participants
were randomized to one of the 3 groups and dosed once daily for two
weeks. Trial participants were followed for a total of 24 weeks, to
monitor for long-term safety, colonization dynamics, and additional
recurrent CDI episodes.
The primary objective of the trial was to establish a dose
regimen for a potential Phase 3 clinical trial, based on the safety
and efficacy of the VE303 regimens compared with placebo. The
primary efficacy endpoint of the trial was the CDI recurrence rate
in each of the 3 groups within 8 weeks after the start of dosing.
At 8 weeks, efficacy outcomes were assessed for 78 patients: 29
from the high-dose group, 27 from the low-dose group, and 22 from
the placebo group.
The topline efficacy results are based on a prespecified
analysis conducted after all patients had reached the Week 8 visit,
using the intent-to-treat population.
The high dose of VE303 met the primary endpoint of a lower
recurrence rate within 8 weeks versus placebo (13.8 percent versus
45.5 percent) using a prespecified analysis that incorporated the
results of toxin and PCR testing, or a clinician’s diagnosis and
treatment of a CDI recurrence when no stool sample was available
for testing. This 31.7 percent reduction in absolute risk of
recurrence reflects a greater than 80 percent reduction in the odds
of a recurrence in the high-dose group compared with the placebo
group (odds ratio 0.192; 90 percent confidence interval 0.048,
0.712; p=0.0077).
Through the Week 8 timepoint, the proportion of these high-risk
patients remaining recurrence-free in the high-dose cohort was 86.2
percent, compared with 54.5 percent of the placebo recipients
remaining recurrence-free at that timepoint. Using C. difficile
toxin testing alone to define recurrence, which has been
historically reported to miss 20 to 50 percent of CDI cases, was
not a robust enough analysis to demonstrate a statistically
significant difference between either of the active treatment
groups and the placebo group.
“Although a number of antibiotics are approved to treat C.
difficile infection, recurrence occurs frequently—often
repeatedly—and is a major cause of morbidity and mortality. The
CONSORTIUM trial is the first randomized, controlled trial to show
that a defined bacterial consortium has the potential to prevent
recurrent C. difficile infection, using an analysis that follows
standard clinical practice in relying upon physician assessment,
along with results of toxin and PCR testing, to establish a C.
difficile diagnosis,” said Mark H. Wilcox, M.D., Professor of
Medical Microbiology at the University of Leeds and a prominent CDI
expert. “As defined bacterial consortia can provide consistent
composition and quality and do not rely on feces obtained from
human donors for manufacture or delivery, VE303 may address some of
the potential issues with lack of product consistency, scalability,
and risk of infection associated with existing approaches.”
Overall, VE303 was observed to be generally well-tolerated in
the trial. Most participants reported one or more adverse events,
but in similar proportions across groups. Few serious adverse
events were reported in the trial, and none were determined to be
treatment-related by either the trial investigators or Vedanta.
The final results and statistical analysis will be available
following completion of long-term safety follow-up and locking of
the complete trial database. Vedanta intends to present the final
data analysis at a future medical conference.
Based on the Phase 2 data, BARDA has exercised its first
contract option for additional funding of $23.8 million pursuant to
its existing 2020 contract with Vedanta. Total committed funding
under the BARDA award to date is $31.2 million, inclusive of this
first contract option. The contract provides for reimbursement of
up to $76.9 million, subject to additional prespecified milestones
being achieved and the availability of funding.
About VE303 VE303 is an orally administered,
investigational live biotherapeutic product (LBP) in development
for the prevention of recurrent C. difficile infection in patients
at high risk for recurrence. 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. VE303 consists of
a defined consortium of eight well-characterized strains of live
bacteria designed to restore colonization resistance against gut
pathogens. 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 BARDA in 2020 to support clinical studies of
VE303. VE303 was granted Orphan Drug Designation in 2017 by the
U.S. 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
treatment of high-risk C. difficile infection, inflammatory bowel
diseases, advanced or metastatic cancers, 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 40 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 LBP candidates containing
pure, clonally derived bacterial consortia in powdered form.
Vedanta Biosciences was founded by PureTech Health (LSE: PRTC,
Nasdaq: 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 statements that are or may be
forward-looking statements, including statements that relate to our
expectation regarding Vedanta’s plans to initiate a Phase 3 pivotal
trial for VE303 and the associated timing, 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 and uncertainties that could cause actual
results, performance and achievements to differ materially from
current expectations, including, but not limited to those risks and
uncertainties described in the risk factors included in the
regulatory filings for PureTech Health plc. 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, neither the company
nor any other party intends to update or revise these
forward-looking statements, whether as a result of new information,
future events or otherwise.
This project has been supported 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.
75A50120C00177.
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version on businesswire.com: https://www.businesswire.com/news/home/20211005005154/en/
Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com U.S. Media Nichole Sarkis +1 774 278
8273 nichole@tenbridgecommunications.com
PureTech Health (NASDAQ:PRTC)
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