PureTech Founded Entity Vedanta Biosciences Announces First Patient Dosed in Phase 2 Clinical Trial of VE202 for the Treatment of Ulcerative Colitis and Receives Fast Track Designation

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, announced that the first patient in the Phase 2 COLLECTiVE202 clinical study of VE202 was dosed.

Vedanta also announced that the U.S. Food and Drug Administration granted Fast Track designation to Vedanta’s defined bacterial consortium candidate, VE202, for the treatment of ulcerative colitis. Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

The full text of the announcement from Vedanta is as follows:

Vedanta Biosciences Announces First Patient Dosed in Phase 2 Clinical Trial of VE202 for the Treatment of Ulcerative Colitis and Receives Fast Track Designation

VE202 is an orally administered, rationally-defined bacterial consortium candidate for the treatment of ulcerative colitis

First patient dosed in the global Phase 2 COLLECTiVE202 study

CAMBRIDGE, MA, October 4, 2023 – Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that the first patient in the Phase 2 COLLECTiVE202 clinical study of VE202 was dosed. Vedanta also announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vedanta’s defined bacterial consortium candidate, VE202, for the treatment of ulcerative colitis (UC). Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

“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,” said Jeffrey Silber, M.D., Chief Medical Officer of Vedanta Biosciences. “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 favorable safety profile. We look forward to advancing this program as we work to address an important unmet medical need.”