VE202 is an orally administered,
rationally-defined bacterial consortium candidate for the treatment
of ulcerative colitis
Vedanta’s pipeline also includes VE303, its
Phase 3 ready therapeutic candidate designed for the prevention of
recurrent Clostridioides difficile infection as well as additional
candidates being evaluated for inflammatory bowel diseases and
Gram-negative infections
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 in the Phase 2 COLLECTiVE202 clinical study of VE202
was dosed.
Vedanta also announced that the U.S. Food and Drug
Administration granted Fast Track designation to Vedanta’s defined
bacterial consortium candidate, VE202, for the treatment of
ulcerative colitis. Fast Track designation is a process designed to
facilitate the development and expedite the review of drugs that
treat serious conditions and fill an unmet medical need.
The full text of the announcement from Vedanta is as
follows:
Vedanta Biosciences Announces First Patient
Dosed in Phase 2 Clinical Trial of VE202 for the Treatment of
Ulcerative Colitis and Receives Fast Track Designation
VE202 is an orally administered,
rationally-defined bacterial consortium candidate for the treatment
of ulcerative colitis
First patient dosed in the global Phase 2
COLLECTiVE202 study
CAMBRIDGE, MA, October 4, 2023 – 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 in the Phase 2 COLLECTiVE202
clinical study of VE202 was dosed. Vedanta also announced that the
U.S. Food and Drug Administration (FDA) granted Fast Track
designation to Vedanta’s defined bacterial consortium candidate,
VE202, for the treatment of ulcerative colitis (UC). Fast Track
designation is a process designed to facilitate the development and
expedite the review of drugs that treat serious conditions and fill
an unmet medical need.
“Despite the fact that up to half of all patients with
inflammatory bowel disease may be in remission at any given time,
long-term follow-up data demonstrate that most will relapse at some
point. Although new therapies for ulcerative colitis are
efficacious for many, they are often accompanied by potential
safety concerns, including risk of infection,” said Jeffrey Silber,
M.D., Chief Medical Officer of Vedanta Biosciences. “We are pleased
that the FDA has granted Fast Track designation for VE202. We
believe this candidate could offer patients with ulcerative colitis
an alternative approach to treatment, with a favorable safety
profile. We look forward to advancing this program as we work to
address an important unmet medical need.”
In a Phase 1 study in healthy volunteers, VE202 strains
colonized robustly and durably following vancomycin pretreatment,
in both a dose- and duration-dependent manner. In addition, VE202
accelerated the conversion of primary bile acids to
immunomodulating secondary bile acids that protect against
intestinal inflammation compared to placebo. VE202 was also well
tolerated, with no treatment-related serious adverse effects.
COLLECTiVE202 is a double-blind, placebo-controlled, randomized
clinical trial that is being conducted at sites in the United
States and Europe. The study is enrolling 100 patients with
mild-to-moderate UC between the ages of 18 and 75 years. Either
VE202 or placebo is added to background therapy and Vedanta will
assess two different regimens, enabling all study participants to
have an opportunity to receive VE202. Primary endpoints are safety
and endoscopic response; secondary endpoints include clinical
response and remission, along with additional endoscopic,
histologic, colonization, inflammatory and immune biomarkers, and
quality-of-life measures.
About VE202
VE202 is a first-in-class, orally administered, investigational
live biotherapeutic product (LBP) consortium consisting of 16
strains of bacteria, which were rationally selected to induce
immune tolerance in the gut, reverse the gut microbiota
abnormalities that are common in patients with inflammatory bowel
disease (IBD), and strengthen the epithelial barrier. Results
describing the biology and candidate selection of VE202 were
previously published in Science and Nature (multiple). VE202 was
granted Fast Track designation in 2023 by the U.S. Food and Drug
Administration (FDA) for the treatment of UC.
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 pipeline includes clinical-stage
product candidates being evaluated for the prevention of recurrent
C. difficile infection and inflammatory bowel diseases and a
preclinical candidate for the prevention of Gram-negative
infections. In addition, the company supports
investigator-sponsored studies in various diseases. These
investigational therapies are grounded in our team’s pioneering
research – published in leading journals including Science, Nature,
Cell, and JAMA – 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 70 patents and has
built what it believes is the industry-leading platform for
development of defined bacterial consortia drugs. This platform
includes one of the largest libraries of bacteria derived from the
human microbiome, vast datasets from human interventional studies,
proprietary capabilities in consortium design, and end-to-end
capabilities for CGMP-compliant manufacturing of oral drug
candidates spanning cell banking, fermentation, lyophilization, and
fill finish.
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 27 therapeutics and therapeutic candidates,
including two (Plenity® and EndeavorRx®) that have received both US
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 VE202’s Fast Track Designation
by the FDA, timing of the Phase 2 COLLECTiVE202 study of VE202 and
Vedanta’s and PureTech’s 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, 2022 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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PureTech Public Relations
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U.S. Media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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