Positive top-line Phase II data for VE303 in high-risk C. difficile infection

USA-based microbiome company Vedanta Biosciences says that its Phase II clinical trial of VE303, an orally administered investigational live biotherapeutic product in development for the prevention of recurrent Clostridium difficile infection (CDI) in high-risk patients, met its primary endpoint of preventing disease recurrence through Week 8.

VE303 achieved a 31.7% absolute risk reduction in rate of recurrence when compared with placebo, representing a greater than 80% 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, says Vedanta, an affiliate of London-listed PureTech Health (LSE: PRTC), whose shares gained 6% in early trading this morning.

Results trigger BARDA contract option