Microbiome startup Vedanta, while continuing the Phase III process for its Clostridioides difficile candidate for infection, has completed a manufacturing facility to produce the drug.
Vedanta’s new 7,000 square foot facility in Cambridge, MA, is designed to manufacture clinical and commercial supplies for its portfolio, including their vs. hard candidate VE303.
The facility is an extension of the company’s existing manufacturing capabilities and can produce multiple drug candidates, according to Vedanta. It also has CGMP capabilities to handle everything from clinical development to commercial launch. Manufacturing is expected to start in the fourth quarter of this year.
The installation cost and job details were not disclosed to Endpoint News, however, Vedanta confirmed in an email that government funds had flowed to the company. The company is a BARDA-funded contractor and support went to Vedanta’s core program and some aspects of the design and commissioning of the facility, Vedanta said.
In October 2021, positive Phase II results triggered a $23.8 million option from BARDA. The funds were used to support the nominee in several functions, including manufacturing.
“This facility, combined with the expertise and talent of our team, is designed to manufacture our microbiome product candidates as standardized compositions with consistent quality attributes at scale,” said Vedanta CEO Bernat Olle. , in a press release.
The company’s first production runs at the new facility will provide a planned Phase III study of VE303, but the timeline for that trial was not disclosed to Endpoints.
Vedanta has been implicated lately with its lead candidate. In 2021, he completed a $68 million Series D raise, which included a $25 million equity investment from Pfizer. The company raked in a C-round of $45.5 million in 2019.