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 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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