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Vedanta Positive Phase 2 Data in C. Diff Infection
Vedanta Positive Phase 2 Data in C. Diff Infection.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 9762N\n PureTech Health PLC\n 05 October 2021\n \n \n \n \n 5 October 2021\n \n \n PureTech Health plc\n \n \n \n \n \n PureTech Founded Entity Vedanta Announces Positive Topline Phase 2 Data for VE303 in High-Risk C. difficile Infection and Exercise of $23.8 Million Option by BARDA \n \n \n \n \n \n \n High-dose VE303 in Phase 2 trial achieved primary endpoint, with 31.7% absolute risk reduction in rate of \n \n \n recurrence\n \n \n (\n \n \n or a greater than 80% reduction in the odds of a recurrence) at 8 weeks when\n \n \n \n \n \n compared with placebo \n \n \n \n \n \n \n Represents most advanced clinical trial of a rationally defined bacterial consortium candidate\n \n \n \n \n \n BARDA exercises $23.8 million option to support Phase 3 clinical trial of VE303, to initiate in 2022 \n \n \n \n \n \n \n \n PureTech Health plc\n \n \n (Nasdaq: PRTC, LSE: PRTC) (\"PureTech\" or the \"Company\"), a clinical-stage biotherapeutics company, is pleased to note that its Founded Entity, Vedanta Biosciences (\"Vedanta\") today announced that its Phase 2 clinical trial of VE303, an orally administered investigational live biotherapeutic product in development for the prevention of recurrent C. difficile infection (CDI) in high-risk patients, met its primary endpoint of preventing disease recurrence through Week 8. VE303 achieved\n \n a 31.7 percent absolute risk reduction in rate of recurrence when compared with placebo, representing a greater than 80 percent reduction in the odds of a recurrence. This is the most advanced clinical trial of an investigational drug based on a rationally defined bacterial consortium, a microbiome-based therapeutic approach that delivers orally administered candidates of precisely known composition that can be manufactured with pharmaceutical-grade consistency. \n \n \n \n \n \n Based on the Phase 2 data, the Biomedical Advanced Research and Development Authority (BARDA) has exercised its first contract option for additional funding \n of $23.8 million, pursuant to its existing 2020 contract with Vedanta, to support the Phase 3 clinical trial of VE303, which Vedanta plans to initiate in 2022.\n \n \n \n \n \n The full text of the announcement from Vedanta is as follows:\n \n \n \n \n \n Vedanta Announce...