RCS - PureTech Health PLC - PRTC's Vedanta Announces VE202 Phase 2 Results

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RNS Number : 2317V  PureTech Health PLC  13 August 2025

13 August 2025

PureTech Health plc

 

PureTech Founded Entity Vedanta Biosciences Announces Phase 2 Study of VE202
in Ulcerative Colitis Did Not Meet Primary Endpoint

 

VE202 was well tolerated, with no reports of treatment-related serious adverse
events

 

Additional analyses from COLLECTiVE202 to be shared in upcoming scientific
forums

 

Vedanta to focus resources on ongoing Phase 3 RESTORATiVE303 registrational
study of VE303 in recurrent Clostridioides difficile infection

 

PureTech Health plc
(https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpuretechhealth.com%2F&data=05%7C02%7CAMT%40puretechhealth.com%7C657f35752e304a460aac08ddda06cff0%7C0b1663cc5eee4bf8a6a5172d9c5379e2%7C0%7C0%7C638906444974391992%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ngNcHhizAzVTk1STSNdjVz6Rm7nffMlwYBJMc3O594U%3D&reserved=0)
(Nasdaq: PRTC, LSE: PRTC) ("PureTech"), noted that its Founded Entity, Vedanta
Biosciences, ("Vedanta") a late clinical-stage biopharmaceutical company
developing microbiome-based oral therapies for gastrointestinal diseases,
today announced that its candidate VE202 did not meet the primary endpoint in
the Phase 2 COLLECTiVE202 study for the treatment of patients with
mild-to-moderate ulcerative colitis (UC).

 

Vedanta remains focused on advancing its lead program, VE303, for the
prevention of recurrent Clostridioides difficile infection (CDI). Ulcerative
colitis and CDI are distinct diseases with different underlying biology, and
VE202 and VE303 have different bacterial compositions and mechanisms of
action. VE303 has demonstrated positive Phase 2 results, reducing CDI
recurrence risk by more than 30% compared with placebo, and is currently being
evaluated in the global, registrational Phase 3 RESTORATiVE303 study. The
program has received both Fast Track and Orphan Drug designations from the FDA
and, if approved, is positioned to become the first live biotherapeutic
product for any indication. Vedanta is also advancing VE707, designed to
prevent infections caused by multidrug-resistant organisms, with an IND
submission planned for 2026.

 

Over the course of 2025, PureTech's ownership stake in Vedanta has been
diluted to 4.2% on a fully diluted basis.

 

The full text of the announcement from Vedanta is as follows:

 

Vedanta Biosciences Announces Phase 2 Study of VE202 in Ulcerative Colitis Did
Not Meet Primary Endpoint

VE202 was well tolerated, with no reports of treatment-related serious adverse
events

 

Additional analyses from COLLECTiVE202 to be shared in upcoming scientific
forums

 

Vedanta to focus resources on ongoing Phase 3 RESTORATiVE303 registrational
study of VE303 in recurrent Clostridioides difficile infection

 

CAMBRIDGE, Mass., August 13, 2025 - Vedanta Biosciences
(https://www.vedantabio.com/) , a late clinical-stage biopharmaceutical
company developing microbiome-based oral therapies for gastrointestinal
diseases, today announced that its candidate VE202 did not meet the primary
endpoint of endoscopic response in the Phase 2 COLLECTiVE202 study for the
treatment of patients with mild-to-moderate ulcerative colitis (UC).

 

"We are very disappointed that our study did not meet its efficacy endpoints,
and our greatest regret is that people living with inflammatory bowel disease
will not, for now, have the opportunity to benefit from a new treatment
option," said Bernat Olle, Ph.D., Chief Executive Officer of Vedanta
Biosciences. "The gut microbiome is a well-recognized driver of IBD, yet
remains a facet of the disease untouched by current treatments. As a field, we
have not yet succeeded in making a meaningful impact for people with IBD
through microbiome-based approaches, but every study moves us closer to that
goal. We are committed to sharing further analyses of this study at upcoming
scientific meetings to help chart new paths forward.

 

"Our priority at Vedanta remains the successful execution of our ongoing
global pivotal study of VE303 for the prevention of recurrent C. difficile
infection, with the goal of potentially delivering the first approved Live
Biotherapeutic Product in any indication - and, in doing so, addressing a
serious health condition with a significant unmet medical need," concluded Dr.
Olle.

 

In the randomized, placebo-controlled COLLECTiVE202 study, endoscopic and
clinical responses were assessed using standardized criteria, and the observed
response rates in the VE202 group were not statistically different from those
in the placebo group. VE202 was generally safe and well tolerated - most
adverse events were mild or moderate in intensity, with no reports of
treatment-related serious adverse events. Analyses of bacterial colonization,
histological findings, and immune responses are ongoing and will be shared in
future scientific forums.

Vedanta remains focused on advancing its other pipeline programs:

 

1.   VE303: Vedanta is currently enrolling patients into RESTORATiVE303, a
registrational Phase 3 study of VE303 for the prevention of recurrent C.
difficile infection (rCDI) at over 200 sites in 24 countries. The Phase 3
program is supported by results from a positive Phase 2 study, in which VE303
demonstrated potentially best-in-disease efficacy with a 30.5% absolute risk
reduction compared with placebo and greater than 80% reduction in the odds of
a CDI recurrence.

2.   VE707: Vedanta is also advancing VE707 to prevent infections by
multidrug-resistant organisms that affect a wide range of vulnerable
populations in areas such as oncology, urology, transplantation, and critical
care, with IND submission planned for 1H 2026.

 

About the COLLECTiVE202 Study

COLLECTiVE202 is a double-blind, placebo-controlled, randomized clinical trial
conducted at sites in the United States, Europe, and Australia. The study
enrolled 114 patients, between the ages of 18 and 75 years, with
mild-to-moderate ulcerative colitis who had not been exposed to any biologic
or advanced oral therapies. Either VE202 (N=57) or placebo (N=57) was added to
a patient's stable background ulcerative colitis therapy. The primary
endpoints were safety and Week 8 endoscopic response (defined as a reduction
of at least 1 point on the Mayo endoscopic subscore). Secondary endpoints
included clinical response and remission, endoscopic improvement and
remission, as well as histological assessments and measures of colonization,
quality-of-life and inflammatory biomarkers. For more information on
COLLECTiVE202 (NCT05370885), visit clinicaltrials.gov.

 

About Vedanta Biosciences

Vedanta Biosciences (https://www.vedantabio.com/) is a clinical-stage
biopharmaceutical company developing microbiome-based oral medicines for the
treatment of gastrointestinal diseases. The company's lead asset is a
potential first-in-class therapy, VE303, currently in a global Phase 3
registrational trial for prevention of recurrent C. difficile infection.
Vedanta leverages its proprietary industry-leading product engine to develop
therapeutic drug candidates based on defined bacterial consortia. The product
engine is supported by broad foundational intellectual property and spans the
development lifecycle from discovery to commercialization. It 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 portfolio 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 three that have been approved by the U.S. Food and Drug
Administration. 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 portfolio 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 Vedanta's development plans, the
applicability of the platform, potential benefits to patients, and Vedanta's
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, 2024, 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

Justin Chen

+1 609 578 7230

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

 

 

 

 

 

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