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(Alliance News) - PureTech Health PLC on Wednesday said its subsidiary Vedanta Biosciences has received fast-track designation for its VE202 treatment.
The Boston-based biotechnology company said the US Food & Drug Administration fast track designation for VE202 for the treatment of ulcerative colitis. The designation is designed to accelerate the development and review of drugs that treat serious conditions or tackle unmet medical needs.
VE202 is an orally administered live biotherapeutic intended to "induce immune tolerance in the gut, reverse the gut microbiota abnormalities that are common in patients with inflammatory bowel disease", it said.
The firm also noted that it has commenced its phase 2 clinical trial of VE202 to treat ulcerative colitis, having dosed the first patient.
Vedanta Chief Medical Officer Jeffrey Silber said: "Despite the fact that up to half of all patients with inflammatory bowel disease may be in remission at any given time, long-term follow-up data demonstrate that most will relapse at some point. Although new therapies for ulcerative colitis are efficacious for many, they are often accompanied by potential safety concerns, including risk of infection.
"We are pleased that the FDA has granted Fast Track designation for VE202. We believe this candidate could offer patients with ulcerative colitis an alternative approach to treatment, with a favourable safety profile."
PureTech shares rose 5.2% to 175.80 each on Wednesday afternoon in London.
By Harvey Dorset, Alliance News reporter
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