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Vedanta Fast Track Designation & Ph2 Data at DDW
Vedanta Fast Track Designation & Ph2 Data at DDW.
About this update from Puretech Health Plc
[{"type":"text","content":"\n\n9 May 2023\n \nPureTech Health plc\n \nPureTech Founded Entity Vedanta Biosciences Receives Fast Track Designation for VE303 and Presents Phase 2 Data at Digestive Disease Week\n \nVE303 receives Fast Track designation for prevention of recurrent C. difficile infection ahead of global pivotal Phase 3 study\n \nExploratory analyses from the VE303 Phase 2 CONSORTIUM study identify statistically significant relationships between VE303 bacterial species and multiple parameters that provide further mechanistic support for VE303's observed efficacy\n \nPureTech 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 U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vedanta's defined bacterial consortium candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (rCDI). 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.\n \nVedanta also announced the details of a podium presentation of research informed by the VE303 Phase 2 CONSORTIUM study at Digestive Disease Week (DDW) 2023, held in Chicago, Illinois from May 6-9. The analyses review multiple aspects of the pharmacodynamic response to VE303 in patients at high risk for rCDI, including how safety and efficacy correlate with dosing regimen, consortium strain colonization, metabolic changes, and restoration of a patient's gut microbial community. The strong correlation between the presence of VE303 strains and both beneficial metabolic changes and nonrecurrence of CDI provides mechanistic support for the study's observed efficacy results.\n \nThe full text of the announcement from Vedanta is as follows: \n \nVedanta Biosciences Receives Fast Track Designation for VE303 and Presents Phase 2 Data at Digestive Disease Week\n \nVE303 receives Fast Track designation for prevention of recurrent C. difficile infection ahead of global pivotal Phase 3 study\n \nExploratory analyses from the VE303 Phase 2 CONSORTIUM ...