VE202 / J&J, Vedanta Biosci - LARVOL DELTA

VE202-002: VE202 in Patients With Mild-to-Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Vedanta Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PureTech Founded Entity Vedanta Biosciences Announces First Patient Dosed in Phase 2 Clinical Trial of VE202 for the Treatment of Ulcerative Colitis and Receives Fast Track Designation (Businesswire) - "PureTech Health plc...noted today that its Founded Entity, Vedanta Biosciences...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 • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Vedanta Biosciences, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2025 ➔ Nov 2025 | Trial primary completion date: Jun 2024 ➔ Jul 2025

Enrollment open • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Vedanta Biosciences Announces $106.5 Million Financing to Advance Pipeline of Defined Bacterial Consortia Therapies (Businesswire) - "Funds will also support Phase 2 study of VE202 for ulcerative colitis, to begin in 2Q 2023...Vedanta Biosciences...announced that it has raised $106.5 million to support pivotal-stage development of its lead candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI), and a Phase 2 study of VE202 for ulcerative colitis, among other development activities."

Financing • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Vedanta Biosciences, Inc. | Initiation date: Jan 2023 ➔ May 2023

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Vedanta Biosciences, Inc. | Initiation date: Jun 2022 ➔ Jan 2023

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DURABLE COLONIZATION OF THE RATIONALLY DESIGNED LIVE BIOTHERAPEUTIC PRODUCTS VE202 AND VE818 IN HEALTHY VOLUNTEERS (DDW 2022) - "Dose duration was an important driver of strain persistence in the long-term, with the highest number of strains colonizing across the acute, durable, and long-term sampling periods. Conclusion VE202 and VE818 were well tolerated in subjects and robustly colonized healthy volunteers after vancomycin pre-treatment."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Transplantation

Vedanta Presents Data from Multiple Studies at Digestive Disease Week 2022 Annual Meeting (Businesswire) - P1 | N=31 | "Safety and colonization analyses of VE202 and VE818 Phase 1 studies show they were well tolerated, colonized robustly after vancomycin pretreatment, and were associated with increased production of secondary bile acids that are known to induce immune tolerance."

P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Vedanta Biosciences, Inc.

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Vedanta Biosciences Publishes Phase 1a/1b Results for Lead Program VE303 in Cell Host & Microbe and Highlights Planned Presentations of Phase 2 VE303 Results (Businesswire) - "Vedanta will present three abstracts at Digestive Disease Week (DDW) 2022, held virtually and in person in San Diego, California, from May 21-24, 2022....One abstract is focused on VE202, a defined bacterial consortium candidate being developed as an oral treatment for inflammatory bowel disease."

Clinical data • Immunology • Inflammatory Bowel Disease

Study of VE202 in Patients with Ulcerative Colitis (clinicaltrialsregister.eu) - P2; N=100; Ongoing; Sponsor: Vedanta Biosciences, Inc.

Clinical • New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Vedanta Biosciences Completes $68 Million Series D Financing (Businesswire) - "Proceeds expected to be used primarily to support a Phase 3 trial of lead candidate VE303 in Clostridioides difficile infection (CDI) and a Phase 2 trial of VE202 in inflammatory bowel disease (IBD)...Plans to initiate Phase 2 trial of VE202 for treatment of mild to moderate ulcerative colitis in H2 2021...Vedanta Biosciences, Inc...announced the closing of a $68 million Series D financing and provided a pipeline update."

Financing • New P2 trial • Inflammatory Bowel Disease

Vedanta Biosciences Presents New Data from Phase 1 Study of VE202, Its Rationally-Defined Consortium for the Treatment of Inflammatory Bowel Disease, at the International Human Microbiome Consortium Congress 2021 (IHMC) (Businesswire) - P1, N=31; "Vedanta Biosciences...announced additional results from a Phase 1 study in healthy volunteers of VE202, the Company’s 16-strain live biotherapeutic product (LBP) candidate for inflammatory bowel disease (IBD). The new data were presented at the International Human Microbiome Consortium Congress 2021 (IHMC), being held virtually from June 27-29th...All doses of the 16-strain consortium were generally safe and well-tolerated, with no reports of VE202-related serious adverse events...Vedanta plans to initiate a Phase 2 clinical trial of VE202 in patients with mild to moderate ulcerative colitis in the second half of 2021."

New P2 trial • P1 data • Inflammatory Bowel Disease • Ulcerative Colitis

PureTech Founded Entity Vedanta Biosciences Announces $25 Million Investment from Pfizer Inc. (Businesswire) - "PureTech Health plc...announced that Pfizer Inc...has made a $25 million investment in Vedanta, as part of the Pfizer Breakthrough Growth Initiative. Vedanta intends to use the proceeds to fund a Phase 2 study of VE202 in inflammatory bowel disease (IBD), which it plans to initiate in 2021."

Financing • New P2 trial • Inflammatory Bowel Disease

Vedanta Biosciences Announces Additional Pharmacokinetics Data From Phase 1 Study of VE202 for Inflammatory Bowel Disease to Be Presented at United European Gastroenterology Week 2020 (Businesswire) - P1, N=74; NCT03723746; Sponsor: Janssen Research & Development, LLC; "Vedanta plans to take the VE202 program forward into a Phase 2 study in inflammatory bowel disease in 2021....The data presented at UEG Week focus on 74 healthy volunteers treated with an 11-strain consortium of VE202 or a placebo. Results include: The consortium colonized the gut abundantly and above background strains detected by qPCR. Colonization was most effective with vancomycin pre-treatment followed by multiple doses of the consortium. In multiple-day dosing cohorts, vancomycin pretreatment reduced microbial density and was required for sustained detection of VE202 compared to non-vancomycin pre-treated cohorts. In these cohorts, VE202 strains were detected up to six months post-treatment."

New P2 trial • P1 data • Inflammatory Bowel Disease

[VIRTUAL] TREATMENT OF ADULTS WITH THE CLOSTRIDIA STRAIN LIVE BIOTHERAPEUTIC PRODUCT VE202 RESULTS IN SUSTAINED AND DURABLE COLONIZATION OF THE HEALTHY HUMAN GUT (UEGW 2020) - P1 | "Two multi-day dosing cohorts (4 and 6) were pretreated with vancomycin (125mg, qid) for five days prior followed by a one-day washout prior to dosing. VE202 strains rapidly, abundantly, and durably colonize the gut of healthy volunteers above natural background strains detected by qPCR. Dense longitudinal sampling and inclusion of placebo controls employed in this study demonstrate that patterns of colonization dynamics correlate with dose and are influenced by antibiotic pre-treatment. Unexpectedly, placebo antibiotic pre-treated subjects co-housed with active drug treated subjects also demonstrated low level VE202 strain specific colonization although at significantly lower RA levels."

Clinical

[VIRTUAL] TREATMENT OF ADULTS WITH THE CLOSTRIDIA STRAIN LIVE BIOTHERAPEUTIC PRODUCT VE202 RESULTS IN SUSTAINED AND DURABLE COLONIZATION OF THE HEALTHY HUMAN GUT (UEGW 2020) - P1 | "Two multi-day dosing cohorts (4 and 6) were pretreated with vancomycin (125mg, qid) for five days prior followed by a one-day washout prior to dosing. VE202 strains rapidly, abundantly, and durably colonize the gut of healthy volunteers above natural background strains detected by qPCR. Dense longitudinal sampling and inclusion of placebo controls employed in this study demonstrate that patterns of colonization dynamics correlate with dose and are influenced by antibiotic pre-treatment. Unexpectedly, placebo antibiotic pre-treated subjects co-housed with active drug treated subjects also demonstrated low level VE202 strain specific colonization although at significantly lower RA levels."

Clinical

[VIRTUAL] TREATMENT OF ADULTS WITH THE CLOSTRIDIA STRAIN LIVE BIOTHERAPEUTIC PRODUCT VE202 RESULTS IN SUSTAINED AND DURABLE COLONIZATION OF THE HEALTHY HUMAN GUT (UEGW 2020) - P1 | "Two multi-day dosing cohorts (4 and 6) were pretreated with vancomycin (125mg, qid) for five days prior followed by a one-day washout prior to dosing. VE202 strains rapidly, abundantly, and durably colonize the gut of healthy volunteers above natural background strains detected by qPCR. Dense longitudinal sampling and inclusion of placebo controls employed in this study demonstrate that patterns of colonization dynamics correlate with dose and are influenced by antibiotic pre-treatment. Unexpectedly, placebo antibiotic pre-treated subjects co-housed with active drug treated subjects also demonstrated low level VE202 strain specific colonization although at significantly lower RA levels."

Clinical

[VIRTUAL] VE202 - Hepatobiliary Surgery I (ACS-CLINCON 2020) - No abstract available

PureTech Health plc - Half-Year Report (PharmiWeb) - "Vedanta expects to advance VE202 into a Phase 2 study in IBD in 2021."

New P2 trial • Inflammatory Bowel Disease

Vedanta Biosciences announces positive topline data from two phase 1 studies of VE202, a rationally defined bacterial consortium being advanced for inflammatory bowel diseases (IBD) (Businesswire) - P1, N=105; "Vedanta Biosciences...today announced positive topline data from two Phase 1 studies in healthy volunteers of VE202...candidate for inflammatory bowel disease (IBD). The studies showed that VE202 was generally safe and well tolerated at all doses and demonstrated durable and dose-dependent colonization. Vedanta expects to begin a Phase 2 study in IBD patients in the next 12 months. Vedanta also announced the receipt of $12 million in additional capital and R&D collaboration funds from new and existing investors...a more complete study dataset and analyses will be submitted to a peer-reviewed journal....Additionally, the European Patent Office (EPO) recently granted Vedanta Biosciences three patents in its foundational intellectual property (IP) family covering the use of bacterial consortia of clostridium species in autoimmune diseases, including IBD."

Financing • New P2 trial • P1 data • Patent • Inflammatory Bowel Disease

HUMAN-DERIVED CLOSTRIDIUM VE202 STRAINS REDUCE ENTEROBACTERIACEAE AND FUSOBACTERIA AND REVERSE EXPERIMENTAL COLITIS INDUCED BY HUMAN GUT MICROBIOTA (DDW 2020) - "Our findings suggest a novel IL-10-independent protective mechanism for human Clostridium VE202 strains, i.e. correction of dysbiosis with reduction of levels of Enterobacteriaceae and Fusobacteria. In addition, VE202 treatment is consistently effective for different human donor microbiota in vivo and in vitro. These results provide a rationale and target for therapeutic use of rationally selected resident protective bacterial cocktails in IBD patients."

Immunology • FOXP3 • IFNG • IL10 • LCN2

HUMAN-DERIVED CLOSTRIDIUM VE202 STRAINS REDUCE ENTEROBACTERIACEAE AND FUSOBACTERIA AND REVERSE EXPERIMENTAL COLITIS INDUCED BY HUMAN GUT MICROBIOTA (CCCongress 2020) - "Our findings suggest a novel IL-10-independent protective mechanism for human Clostridium VE202 strains, i.e. correction of dysbiosis with reduction of levels of Enterobacteriaceae and Fusobacteria. In addition, VE202 treatment is consistently effective for different human donor microbiota in vivo and in vitro. These results provide a rationale and target for therapeutic use of rationally selected resident protective bacterial cocktails in IBD patients."

FOXP3 • IFNG • IL10 • LCN2

Culture-independent Profiling of the Fecal Microbiome to Identify Microbial Species Associated with a Diarrheal Outbreak in Immunocompromised Mice. (PubMed, Comp Med) - "This approach identified 4 bacterial taxa- Candidatus Arthromitus, Clostridium celatum, Clostridiales bacterium VE202-01, and Bifidobacterium pseudolongum strain PV8-2- that were significantly enriched in the affected mice. Based on these results, specific changes were made to the animal husbandry procedures for immunocompromised mice. This case report highlights the utility of culture-independent methods in laboratory animal diagnostics."

Journal • Preclinical

VE-202: PK/PD data from P1 trial in healthy subjects in 2019 (Puretech) - Corporate Presentation

P1 data