Novacta Announces Initiation of Clinical Studies on NVB302 for C. difficile Infection

Celtic Pharma Holdings Advisors LLP has announced that its investee company, Novacta Biosystems Limited has commenced dosing of the first healthy volunteers in a Phase I clinical trial for NVB302, the Company’s orally administered treatment for hospital-acquired Clostridium difficile infections.

Developed with support from a Wellcome Trust Strategic Translation 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 found in the gastrointestinal tract. It has promising activity in both in vitro and in vivo models of CDI.

In preclinical studies, NVB302 was stable in the GI tract and not significantly absorbed into the systemic circulation, thus maximizing drug concentrations at the infection site in the lower GI tract. The compound was well-tolerated and did not cause systemic toxicity.

“We are very pleased to announce the initiation of clinical studies with NVB302,” said Dr. Mike Dawson, Chief Scientific Officer of Novacta “This is a major milestone for the company.”

Dr. Richard Garraway, a Partner in CPHA and member of the Novacta Board of Directors added: “Celtic is delighted that Novacta has achieved this significant milestone. We expect the Company to know the results of this key study in Q3 2012 when we shall be able to assess further the technical and commercial potential of this compound as a development candidate.”

C. difficile is a hospital acquired infection that causes severe diarrhoea and can be life threatening, particularly amongst the elderly. Few of the currently available antibiotics are effective against C. Difficile infection and drug resistance is a growing threat.

Ted Bianco, Director of Technology Transfer at the Wellcome Trust, said “C. difficile is a particularly insidious infection that catches people at their most vulnerable. With the ever present threat of increasing drug resistance, taking this new antibiotic into clinical trials is a significant step on the road to replenishing our depleted medicine cabinet.”