Vedanta Biosciences has reported positive preliminary results from a Phase la/lb clinical trial that evaluated the safety and tolerability of VE303 for gut microbiota restoration after antibiotics.
The open-label, single-centre, single-dose and multiple-dose escalation trial enrolled 23 healthy adult subjects.
During the trial, different doses of VE303 were orally administered to the subjects.
The trial also examined the pharmacokinetics of intestinal colonisation by the VE303 strains and pharmacodynamics of recovery of the gut microbiota after administering antibiotics followed by VE303.
The preliminary results showed that single and multiple doses of VE303, after vancomycin administration, were safe and well-tolerated.
It was also revealed that repeated dosing resulted in increased robustness of strain colonisation, and VE303 speed up microbiota recovery after vancomycin administration in a dose-dependent manner compared to recovery without VE303.
Among other findings, the trial found that adverse events related to VE303 administration occurred in less than one third of the subjects.
Vedanta Biosciences co-founder and CEO Bernat Olle said: “We believe these Phase la/lb results represent a significant milestone for the microbiome field.
“VE303’s favourable safety profile, and - most notably - its ability to rapidly, abundantly, and durably colonise a heterogenous population of healthy adults provides a scientific rationale for use of defined bacterial consortium drugs and moves the field beyond the use of undefined fecal transplants.
“The robust relationship between dose exposure and response we have observed informs a rational dose selection for VE303 Phase ll studies and supports its potential as a first-in-class therapy for prevention of recurrent Clostridium difficile infection.”
Vedanta is expected to begin the Phase ll trial of VE303 in recurrent C. difficile infection by the last quarter of this year.
VE303 is an orally administered, investigational live biotherapeutic product (LBP) created from pure, clonal bacterial cell banks.