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LONDON (Alliance News) - PureTech Health PLC said Thursday affiliate Vedanta Biosciences preliminary results from its clostridium difficile infection study showed the drug is "safe and well-tolerated".
The "successful" phase 1a/1b clinical study in healthy volunteers for its lead, orally-administered live biotherapeutic product showed "rapid, abundant, and durable intestinal colonisation of the VE303 strains".
According to PureTech, this demonstrated a "proof of mechanism for this product candidate consisting of a defined consortium of human microbiome-derived bacteria".
A phase 2 study in the therapeutic indication is expected to begin before the end of the year.
Chief Scientific Officer Joseph Bolen said: "We know that a community of microbes - versus a single strain - is required to re-establish a healthy microbiome since these bacteria work in concert with each other to promote the growth of beneficial bacteria and reduce the levels of pathogenic bacteria. This is the foundation for Vedanta's consortia-based approach, which is now supported by these results and the fact that we were able to track the robust and durable colonisation of each bacterial strain comprising VE303.
"This rational development of proprietary microbiome-based drugs is the hallmark of Vedanta's pipeline, which is expected to include three additional clinical-stage product candidates in IBD, in partnership with Janssen, food allergy, and cancer immunotherapy within the next nine months."
Shares in PureTech were down 0.1% Thursday at 164.53 pence each.
