Vedanta Biosciences wins FDA fast track designation for Clostridioides difficile treatment

Antiobiotics when used to treat CDI are generally succcessful but they can disrupt or perturb the microbiome. Vedanta Biosciences said that as a result of this, 20% or more of those taking antibiotics go on to have recurrent CDI episodes which can get progressively worse. 

On May 8, the clinical-stage biotherapeutics company​ conducted a podium presentation of research informed by the VE303 phase 2 Consortium study at Digestive Disease Week (DDW) 2023, held in Chicago.

The session reviewed multiple aspects of the pharmacodynamic response to VE303 in patients at high risk for CDI, 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.

Clostridioides difficile infection

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.

Building on the positive phase 2 data recently published in The Journal of the American Medical Association (JAMA), the analyses presented at DDW provided 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,” said Jeffrey Silber, chief medical officer of Vedanta.

“Over 150,000 people experience recurrent CDI annually in the US alone, and this requires scalable, effective treatment solutions. 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.”

Later in the year, Vedanta will initiate its ‘pivotal’ global phase 3 study for VE303, RestoratiVE303.