PureTech founded entity, Vedanta Biosciences, has published the results of its Phase 2 trial of VE303, a potential treatment for recurrent Clostridioides difficile infection (CDI), in the Journal of the American Medical Association (JAMA). According to a press release from Vedanta, the VE303 bacterial consortium proved effective in preventing recurrent CDI as compared to a placebo in the study population, and secondary efficacy endpoints analysis found that CDI recurrence rates were lower in the group receiving the therapy. The JAMA publication also included data on the gut microbiome and bacterial strain colonization.

VE303 consists of eight strains of bacteria that were rationally selected from Vedanta’s discovery engine, with the aim of defining a treatment for the prevention of recurrent CDI that could bypass the inconsistent composition of current treatments that are based on donor fecal material. The use of bacterial cell banks allows for a standardized drug product in powdered form.

Vedanta presented its findings from the Phase 2 trial at a late-breaker oral presentation at the annual European Congress of Clinical Microbiology in Infectious Diseases (ECCMID). The presentation was titled “An 8-strain defined bacterial consortium promotes microbiota restoration and limits inflammation in patients with recurrent Clostridioides difficile infection (rCDI)” and also discussed the relationship between VE303 exposure and clinical response from enhanced bacterial colonization, as well as new evidence of inflammation modulation in treated patients.

“The clinical data to-date have been extremely promising, and we are eager to see future updates on this program as it progresses through the clinic,” said Darrell Pardi, M.D. and Chair of the Division of Gastroenterology and Hepatology at the Mayo Clinic in Rochester, Minnesota, the senior author of the JAMA paper.

Jeffrey L. Silber, M.D., Chief Medical Officer of Vedanta, said, “the results of our VE303 Phase 2 study demonstrate the potential utility of reproducible product candidates that are based on defined bacterial strains grown from clonal cell banks, in a manner analogous to monoclonal antibody production.” He added that the VE303 product offers consistent composition and quality attributes, which could provide more consistent clinical benefit, and avoid the risk of pathogen transfer from donor stool, as there is no donor.

VE303 is just one of the many next-generation oral therapies based on defined bacterial consortia that Vedanta is developing. The company is currently working with the US Department of Defense to develop oral therapies across different indications, with the aim of providing defense personnel with protection against bioweapon and emerging infectious diseases. The company is also developing therapies for other indications, such as inflammatory bowel disease, food allergy, and immuno-oncology.

Clostridioides difficile is a bacterial infection that affects the digestive system, causing diarrhoea, fever, and abdominal pain. It mostly affects older adults who have recently had medical care or received antibiotics. According to the US Centers for Disease Control and Prevention, approximately 223,900 cases occur in the United States each year, and at least 12,800 people die annually as a result of the infection. The potential for a consistent and effective treatment for CDI offers a significant opportunity for patients, especially those who suffer from recurrent CDI.

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By Sarah Johnson

Sarah Johnson is a renowned investigative journalist with over two decades of experience. She has won several awards for her in-depth reporting on social justice issues, government corruption, and environmental concerns. Sarah's fearless approach to journalism has earned her a reputation as one of the most respected journalists in the industry.

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