PureTech Health
plc
PureTech Founded Entity
Vedanta Biosciences Enrolls First Patient in Pivotal Phase 3
RESTORATiVE303
Study of VE303 for the
Prevention of Recurrent C.
difficile Infection
VE303 is an orally
administered, potential first-in-class live biotherapeutic product
candidate being developed to prevent recurrence of
Clostridioides difficile infection (CDI)
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 that the first patient
has been dosed in the global Phase 3 RESTORATiVE303 clinical study
of VE303, which is an orally administered defined bacterial
consortium candidate that is being developed for the prevention of
recurrent C. difficile
infection (rCDI). The
RESTORATiVE303 trial is evaluating the efficacy and safety of VE303
in patients with rCDI and is intended to form the basis for a
Biologics License Application to be filed with the U.S. Food and
Drug Administration.
The full text of the announcement
from Vedanta is as follows:
Vedanta Biosciences Enrolls
First Patient in Pivotal Phase 3 RESTORATiVE303
Study of VE303 for the
Prevention of Recurrent C.
difficile Infection
VE303 is an orally
administered, potential first-in-class live biotherapeutic product
candidate being developed to prevent recurrence of
Clostridioides difficile infection (CDI)
CAMBRIDGE, MA, May 21,
2024 - Vedanta
Biosciences, a clinical-stage company
that is developing a potential new category of oral therapies based
on defined bacterial consortia, today announced that the first
patient has been dosed in the global Phase 3 RESTORATiVE303
clinical study. VE303 is an orally administered defined bacterial
consortium candidate that is being developed for the prevention of
recurrent C. difficile
infection (rCDI). The
RESTORATiVE303 trial is evaluating the efficacy and safety of VE303
in patients with rCDI and is intended to form the basis for a
Biologics License Application (BLA) to be filed with the U.S. Food
and Drug Administration.
"Initiation of the RESTORATiVE303
study represents a key clinical milestone for the VE303 program.
Building on the successes of earlier VE303 clinical studies,
RESTORATiVE303 is the first pivotal Phase 3 study of a live
biotherapeutic product for prevention of recurrent CDI, a
potentially serious infection that affects up to 175,000 patients
and results in approximately 20,000 deaths annually in the U.S.,"
said Jeffrey Silber, M.D., Chief Medical Officer of Vedanta
Biosciences. "Based on the efficacy and safety data we have
generated to date for this program, we believe that an oral,
rationally designed, defined consortium candidate has the potential
to offer patients with rCDI an attractive alternative to undefined,
donor-derived fecal approaches."
In April 2023, Vedanta
published results from the Phase 2
CONSORTIUM trial, in which treatment with VE303 was associated with
a 30.5% adjusted 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.
"CDI may recur in 25% or more of
those affected, sometimes repeatedly, despite initially successful
antibiotic treatment. With each subsequent recurrence, CDI can have
a severe and worsening effect on quality of life, leading to
hospitalization and increased risk of death," said Paul Feuerstadt,
M.D., FACG, AGAF, of Yale University School
of Medicine, and a RESTORATiVE303 study
investigator. "Precision approaches based on defined bacterial
consortia represent the next generation of microbiome therapeutics
for patients with CDI, and we welcome the opportunity to join the
pivotal study for the first candidate based on this important new
modality."
About the RESTORATiVE303 Study
RESTORATiVE303 is a randomized,
double-blind, placebo-controlled Phase 3 clinical trial evaluating
the safety and efficacy of VE303 in patients at high risk for
recurrence of CDI after completing a course of antibiotics for a
prior CDI episode. The trial is being conducted at approximately
200 sites in 22 countries, across four continents. The primary
endpoint is the comparison of CDI recurrence rates at eight weeks
in the VE303 and placebo groups. The Phase 3 study design and VE303
dosing regimen are based on the completed Phase 2 trial, in which
VE303 met its primary endpoint for preventing CDI recurrence at
eight weeks and was observed to be generally well-tolerated. For
more information on RESTORATiVE303
(NCT06237452)
please visit
clinicaltrials.gov.
About VE303
VE303 is a potential first-in-class
live biotherapeutic product (LBP) candidate consisting of a defined
bacterial consortium designed for the prevention of
recurrent Clostridioides
difficile infection (rCDI). It 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 donor fecal material of inconsistent
composition. Vedanta published study
results in April 2023 from the
Phase 2 CONSORTIUM trial, in which treatment with the VE303
high dose was associated with a 30.5% adjusted 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. VE303 was granted Orphan Drug Designation in 2017 and
Fast Track Designation in 2023 by the U.S. Food and Drug
Administration (FDA) for the prevention of recurrent
CDI.
This project has been funded in part
with federal funds from the U.S. Department of Health and Human
Services (HHS); Administration for Strategic Preparedness and
Response; Biomedical Advanced Research and Development Authority,
under contract number 75A5012C00177 for a contract value up to
$104.2 million. This project has also received a $5.4 million
research grant from the Combating Antibiotic Resistant Bacteria
Biopharmaceutical Accelerator (CARB‑X) in 2017.
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 two that have
received both U.S. FDA clearance and European marketing
authorization and a third (KarXT) that has been filed for FDA
approval. 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 the VE303
development program, development plans and potential benefits to
patients, and our future prospects, developments and strategies.
The forward-looking statements are based on current expectations
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achievements to differ materially from current expectations,
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