Date: 2012-08-06
Type of information:
phase: 1
Announcement: results
Company: Novacta Biosystems (UK)
Product: NVB302
Action
mechanism: Developed with support from a Wellcome Trust Strategic Award, NVB302 is a member of a compound class known as Type B lantibiotics. Lantibiotics are a naturally occurring class of antibiotic peptide compounds found in a large number of bacteria. They take their name from the lanthionine amino acids found within their structure (lanthionine-containing antibiotics). Lantibiotics have demonstrated potential to treat infections caused by agents such as C. difficile and MRSA.
NVB302 is not absorbed, resulting in optimal concentration in the GI tract which is the site of infection. It is highly selective for C. difficile over other members of the normal gut flora, which may translate into improved therapeutic properties (especially recurrence). It also has an excellent resistance prognosis.NVB302 is currently undergoing a phase I clinical trial in healthy volunteers.
Disease: Clostridium difficile infection
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On August 6, 2012, Novacta Biosystems, a UK biotechnology company focused on the discovery and development of novel antibacterial agents, has completed a Phase I clinical trial of NVB302, the Company\'s orally administered treatment for Clostridium difficile infection. 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. The NVB302 programme is supported by the Wellcome Trust.
* On November 2, 2011, Novacta Biosystems has initiated clinical studies on NVB302 for C. difficile infection and has commenced dosing of the first healthy volunteers in a Phase I clinical trial for NVB302, its orally administered treatment for hospital-acquired Clostridium difficile infections. In preclinical studies, NVB302 was stable in the GI tract and not significantly absorbed into the systemic circulation, thus maximising drug concentrations at the infection site in the lower GI tract. The compound was well-tolerated and did not cause systemic toxicity. Novacta Biosystems expects to know the results of this study in Q3 2012.
