The company has built large-scale current cGMP facility has built on the company's existing manufacturing capabilities and can produce multiple drug candidates in a manner compliant with global regulatory standards
Vedanta Biosciences, a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, has opened a new facility designed to manufacture clinical and commercial supply for its therapeutic portfolio.
This portfolio includes the planned Phase 3 study and potential commercial launch of its lead candidate, VE303, in Clostridioides difficile infection.
The large-scale current Good Manufacturing Practice (cGMP) facility builds on the company's existing manufacturing capabilities and can produce multiple drug candidates in a manner compliant with global regulatory standards, supporting Vedanta's clinical expansion. With this facility, Vedanta has cGMP capabilities from clinical development to commercial launch, underscoring its leadership in the discovery, development, and manufacture of drugs based on defined bacterial consortia.
We have industrialised an end-to-end manufacturing process for this class of product candidates, at commercial scale, by solving an array of technical challenges
"We believe that taking a targeted approach to modulation of the human microbiota, using rigorously controlled and defined pharmaceutical-grade compositions, will be instrumental to the evolution of microbiome-based therapies into a reliable new drug modality for patients across a range of indications," said Bernat Olle, CEO of Vedanta Biosciences. "This facility, combined with the expertise and talent of our team, is designed to manufacture our microbiome product candidates as standardised compositions with consistent quality attributes at a large scale."
"We saw early on in Vedanta's existence that the manufacturing capabilities required for this new drug modality were not yet established in our field, particularly those involving consortia of anaerobes or spore-forming strains, which comprise the majority of human intestinal bacteria," said Dan Couto, Chief Operating Officer of Vedanta Biosciences. "Today, we have industrialised an end-to-end manufacturing process for this class of product candidates, at commercial scale, by solving an array of technical challenges related to cGMP production of defined bacterial consortia. We believe this in-house capability mitigates potential delays associated with technology transfer to third parties, empowers us to expedite advancing product candidates that show promise in early studies, and protects key intellectual property and know-how."
Vedanta believes it was the first company to manufacture cGMP-grade defined bacterial consortia in powdered form, which enables stable, consistent oral formulations.
The company has also demonstrated its ability to reliably produce defined bacterial consortia, by manufacturing several hundred CGMP batches encompassing over 30 phylogenetically-diverse anaerobic bacterial species that are representative of the biodiversity in the human gut and advancing five product candidates to the clinic.
The first production runs at the new facility will supply a planned Phase 3 study of VE303, an orally administered, defined bacterial consortium candidate for high-risk Clostridioides difficile (CDI) infection.
Every year, CDI contributes to approximately 45,000 deaths in the US. In a Phase 2 study that enrolled patients at high risk of recurrence, VE303 met its primary endpoint of preventing CDI recurrence at eight weeks. This was the most advanced clinical trial of an investigational drug based on a defined bacterial consortium to date.