TIDMPRTC
PureTech Health PLC
09 May 2023
9 May 2023
PureTech Health plc
PureTech Founded Entity Vedanta Biosciences Receives Fast Track
Designation for VE303 and Presents Phase 2 Data at Digestive
Disease Week
VE303 receives Fast Track designation for prevention of
recurrent C. difficile infection ahead of global pivotal Phase 3
study
Exploratory analyses from the VE303 Phase 2 CONSORTIUM study
identify statistically significant relationships between VE303
bacterial species and multiple parameters that provide further
mechanistic support for VE303's observed efficacy
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
U.S. Food and Drug Administration (FDA) granted Fast Track
designation to Vedanta's defined bacterial consortium candidate,
VE303, for the prevention of recurrent Clostridioides difficile
infection (rCDI). 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.
Vedanta also announced the details of a podium presentation of
research informed by the VE303 Phase 2 CONSORTIUM study at
Digestive Disease Week (DDW) 2023, held in Chicago, Illinois from
May 6-9. The analyses review multiple aspects of the
pharmacodynamic response to VE303 in patients at high risk for
rCDI, including how safety and efficacy correlate with dosing
regimen, consortium strain colonization, metabolic changes, and
restoration of a patient's gut microbial community. The strong
correlation between the presence of VE303 strains and both
beneficial metabolic changes and nonrecurrence of CDI provides
mechanistic support for the study's observed efficacy results.
The full text of the announcement from Vedanta is as
follows:
Vedanta Biosciences Receives Fast Track Designation for VE303
and Presents Phase 2 Data at Digestive Disease Week
VE303 receives Fast Track designation for prevention of
recurrent C. difficile infection ahead of global pivotal Phase 3
study
Exploratory analyses from the VE303 Phase 2 CONSORTIUM study
identify statistically significant relationships between VE303
bacterial species and multiple parameters that provide further
mechanistic support for VE303's observed efficacy
CAMBRIDGE, MA, May 8, 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 U.S. Food and Drug Administration (FDA) granted
Fast Track designation to Vedanta's defined bacterial consortium
candidate, VE303, for the prevention of recurrent Clostridioides
difficile infection (rCDI). 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.
Vedanta also announced the details of a podium presentation of
research informed by the VE303 Phase 2 CONSORTIUM study at
Digestive Disease Week (DDW) 2023, held in Chicago, Illinois from
May 6-9.
The presented analyses review multiple aspects of the
pharmacodynamic response to VE303 in patients at high risk for
rCDI, including how safety and efficacy correlate with dosing
regimen, consortium strain colonization, metabolic changes, and
restoration of a patient's gut microbial community. The strong
correlation between the presence of VE303 strains and both
beneficial metabolic changes and nonrecurrence of CDI provides
mechanistic support for the study's observed efficacy results.
A disrupted intestinal microbiome from recent antibiotic
exposure can lead to overgrowth of C. difficile. In the United
States, approximately 500,000 people develop CDI each year, with
symptoms that can include diarrhea, fever, abdominal pain, and
cramping. Antibiotics are used to treat CDI and are generally
successful, but they can further perturb the microbiome. As a
result, an estimated 20% or more of these patients go on to have
recurrent CDI episodes, which can leave them increasingly
debilitated. Building on the positive Phase 2 data that were
recently published in JAMA , the analyses presented at DDW provide
additional evidence that VE303 strains colonize robustly and work
to more quickly restore a disrupted microbiome to a normal, healthy
state.
"The FDA's decision to grant Fast Track designation to VE303
underscores the continuing need for medical innovation for this
condition. Over 150,000 people experience recurrent CDI annually in
the U.S. alone, and this requires scalable, effective treatment
solutions," said Jeffrey L. Silber, M.D., Chief Medical Officer of
Vedanta Biosciences. "Fecal microbiota transplants and other
donor-derived treatments are often prescribed-they can be
effective, but they can vary greatly in composition and potency,
and they may carry a risk of transmitting infectious agents.
Vedanta's approach of growing the strains for our defined bacterial
consortia from pure clonal cell banks is a highly scalable process
that obviates the need for fecal donors and leads to a consistently
manufactured candidate. We look forward to initiating our global
Phase 3 pivotal study for VE303, RestoratiVE303, later in
2023."
About the VE303 DDW Presentation
Title: Pharmacodynamic response to a defined bacterial
consortium, VE303, in patients with Clostridioides difficile
infection (CDI): Results of the Phase 2 CONSORTIUM study
Presenter: Rajita Menon, Ph.D.
Overview : The research reviews various aspects of the Phase 2
CONSORTIUM study of VE303. The study was a randomized,
double-blind, placebo-controlled, dose-finding trial in individuals
at high risk of rCDI. After completing a course of antibiotics for
a laboratory-confirmed qualifying CDI episode, subjects were
randomized in a 1:1:1 ratio to receive low-dose VE303, high-dose
VE303, or placebo orally once daily for 14 days. In the Phase 2
study, the VE303 high dose arm had an acceptable safety profile and
compared with placebo, reduced the odds of developing rCDI through
Week 8 by over 80%. The VE303 high dose also led to superior VE303
strain colonization at 14 days, achieving long-term engraftment,
and promoted early restoration of the microbiota and beneficial
metabolites.
To aid in the understanding of the mechanisms underlying the
observed clinical efficacy, fecal samples were collected and
analyzed at multiple timepoints. Among the 378 microbial species
identified in these samples, the only ones significantly associated
with non-recurrence were three of the strains in VE303. Several of
the VE303 strains were associated with beneficial metabolic changes
within the first 14 days. These observations suggest that VE303 may
protect against rCDI via multiple mechanisms-both directly, through
growth and preferential establishment of the VE303 strains in the
gut relative to more pathogenic species; and indirectly, through
synthesis of beneficial metabolites and enhanced recovery of the
broader gut microbiome.
This research presentation was developed by Vedanta in
collaboration with researchers at the University of Massachusetts
Medical School and Mt. Sinai School of Medicine.
About VE303
VE303 is a defined bacterial consortium therapeutic candidate
designed for the prevention of recurrent Clostridioides difficile
infection (rCDI). It consists of eight strains that were rationally
selected using Vedanta's discovery 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 direct
sourcing of donor fecal material of inconsistent composition.
Vedanta reported positive topline results in October 2021 from the
Phase 2 CONSORTIUM trial, in which VE303 was associated with a
31.7% 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. Vedanta believes VE303 has the
potential to become a first-in-class therapeutic based on a defined
bacterial consortium. Vedanta Biosciences received a $5.4 million
research grant from the Combating Antibiotic Resistant Bacteria
Biopharmaceutical Accelerator (CARB-X) in 2017. Additionally, the
positive results of the Phase 2 study, first reported in October
2021, triggered a $23.8 million contract option from the Biomedical
Advanced Research and Development Authority (BARDA) to support a
Phase 3 clinical study of VE303. This project has been funded in
part with federal funds from the Department of Health and Human
Services; Administration for Strategic Preparedness and Response;
BARDA, under contract number 75A5012C00177 for a contract value up
to $81.9 million. 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.
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 prevention of recurrent
C. difficile infection, inflammatory bowel diseases, food allergy,
and liver disease. 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 Digestive Disease Week(R)
Digestive Disease Week(R) (DDW) is the largest international
gathering of physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW is an in-person and virtual
meeting from May 6-9, 2023. The meeting showcases more than 3,100
abstracts and hundreds of lectures on the latest advances in GI
research, medicine and technology. More information can be found at
www.ddw.org .
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 (R) and EndeavorRx (R)) that have received
both US FDA clearance and European marketing authorization and a
third ( KarXT ) that is expected to be filed soon 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 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 statements that relate to the VE303's Fast
Track Designation by the FDA, Vedanta's presentation of research
informed by the VE303 Phase 2 CONSORTIUM study at Digestive Disease
Week (DDW) 2023, and Vedanta's and PureTech's future prospects,
development plans, 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, the following: our history of incurring significant operating
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achieve our business goals, which may not be available and which
may force us to delay, limit or terminate certain of our
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potential for substantial delays; potential difficulties with
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