21st May 2024 14:07
(Alliance News) - PureTech Health PLC on Tuesday said that a company it founded and in which it maintains a stake had begun trials of a new treatment for clostridioides difficile infection, in the hopes of moving toward regulatory approval.
The London-based biotherapeutics company said that its company Vedanta Biosciences Inc has enrolled the first patient in phase-3 trials of VE303.
Vedanta is a Massachusetts-based pharmaceutical company, founded by PureTech in 2010, and focused on clinical-stage candidates for the treatment of bacteria-related conditions.
As of December 31, PureTech's stake in the company was 36%.
VE303 is an orally administered drug being developed for the prevention of clostridioides difficile bacterial infections in the colon.
The trial, titled RESTORATiVE303, will evaluate the safety and efficacy of VE303 in patients with this infection, and is intended to form the basis of a biologics licence application with the US Food & Drug Administration, PureTech said.
In early May, VE3030 received a 'Fast Track' designation from the FDA, which expedites the development and review of new drugs which it believes address significant unmet medical needs.
"Initiation of the RESTORATiVE303 study represents a key clinical milestone for the VE303 program, said Jeffrey Silber, chief medical officer at Vedanta. "Building on the successes of earlier VE303 clinical studies, RESTORATiVE303 is the first pivotal phase 3 study of a live biotherapeutic product for prevention of recurrent CDI, a potentially serious infection that affects up to 175,000 patients and results in approximately 20,000 deaths annually in the US."
Shares in PureTech were up 0.4% at 229.50 pence each in London on Tuesday.
By Hugh Cameron, Alliance News reporter
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