Novacta Biosystems Limited completes Phase I study of NVB302 against C. difficile infection in healthy volunteers
Celtic Pharma Holdings Advisors LLP announced that Novacta Biosystems Limited has completed a Phase I clinical trial of NVB302, the Company’s orally administered treatment for Clostridium difficile infection (“CDI”).
Both single ascending dose and multiple ascending dose studies in a total of 64 healthy volunteers revealed NVB302 to be safe and well-tolerated at all doses tested. Consistent with data from preclinical models, there was negligible systemic absorption of the drug and high concentrations were recovered in the faeces.
Developed with support from a Wellcome Trust Strategic Award, NVB302 is a member of a compound class known as Type B lantibiotics. It has properties that make it ideally suited as a new treatment for CDI, including excellent activity against all strains of C. difficile tested whilst having minimal activity against the predominantly Gram-negative natural flora of the gut. NVB302 has exhibited promising activity in both in vitro and in vivo models of CDI.
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