RCS - PureTech Health PLC - PRTC's Vedanta Begins Phase 3 of VE303 in C. diff

Puretech HealthAnnouncement

21/05/2024 12:15

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RNS Number : 1862P  PureTech Health PLC  21 May 2024

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 (https://puretechhealth.com/)  (Nasdaq: PRTC, LSE: PRTC)
("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted
today that its Founded Entity, Vedanta Biosciences
(https://www.vedantabio.com/) , 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
(https://www.vedantabio.com/) , 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
(https://www.vedantabio.com/news-media/press-releases/detail/2955/vedanta-biosciences-publishes-phase-2-results-in-the)
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
(https://www.clinicaltrials.gov/study/NCT06237452?term=NCT06237452&rank=1)
) 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
(https://www.vedantabio.com/news-media/press-releases/detail/2955/vedanta-biosciences-publishes-phase-2-results-in-the)
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  (https://www.vedantabio.com/) 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
(http://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.

 

Contact:

PureTech

Public Relations

publicrelations@puretechhealth.com (mailto:publicrelations@puretechhealth.com)

Investor Relations

IR@puretechhealth.com (mailto:IR@puretechhealth.com)

 

UK/EU Media

Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

puretech@fticonsulting.com (mailto:puretech@fticonsulting.com)

 

US Media

Nichole Bobbyn

+1 774 278 8273

nichole@tenbridgecommunications.com
(mailto:nichole@tenbridgecommunications.com)

 

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