PureTech Founded Entity Vedanta Biosciences Receives Fast Track Designation for VE303 and Presents Phase 2 Data at Digestive Disease Week
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
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
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
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
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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:
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
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
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®
Digestive Disease Week® (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
About
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 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 losses since our inception; our need for additional funding to achieve our business goals, which may not be available and which may force us to delay, limit or terminate certain of our therapeutic development efforts; our limited information about and limited control or influence over our Non-Controlled Founded Entities; the lengthy and expensive process of preclinical and clinical drug development, which has an uncertain outcome and potential for substantial delays; potential difficulties with enrolling patients in clinical trials, which could delay our clinical development activities; side effects, adverse events or other safety risks which could be associated with our therapeutic candidates and delay or halt their clinical development; our ability to obtain regulatory approval for and commercialize our therapeutic candidates; our ability to realize the benefits of our collaborations, licenses and other arrangements; our ability to maintain and protect our intellectual property rights; our reliance on third parties, including clinical research organizations, clinical investigators and manufacturers; our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events; and those additional important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended
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