Celtic Pharma Holdings Advisors LLP has announced that Novacta Biosystems Limited (“Novacta”) 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.
“We are very pleased to announce the completion of our phase I study.” said Dr. Mike Dawson, Chief Scientific Officer of Novacta “The data clearly indicate that NVB302 warrants further investigation as an agent for C. difficile infection.”
CDI is an infection that causes severe diarrhoea and can be life threatening, particularly amongst the elderly. There are few therapeutic alternatives for C. difficile infection and disease recurrence is a serious problem.
Richard Seabrook, Head of Business Development at the Wellcome Trust, said “C. difficile remains a major cause of hospital acquired infections around the world. This announcement from Novacta marks encouraging progress towards developing new, smarter, treatments which combat the problem whilst helping to preserve the normal gut flora.”