Novacta Biosystems Limited completes Phase I study of NVB302 against C. difficile infection in healthy volunteers

06/08/2012

 

Guernsey and London, 6th August 2012 - Celtic Pharma Holdings Advisors LLP ("CPHA") today announces that Novacta Biosystems Limited ("Novacta"), 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 ("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."

NOTES TO EDITORS

About Novacta Biosystems Limited

Novacta Biosystems, part of the Celtic Pharma Holdings group, is a UK-based biotechnology company that specialises in the discovery and development of treatments for infectious diseases. Novacta's lantibiotic platform has given rise to a number of potential antibacterial therapies, including those in the CDI programme. For further information on Novacta's CDI programme and NVB302, please visit our website at www.novactabio.com.

About Celtic Pharma Holdings Advisors LLP

Celtic Pharma Holdings Advisors is a global private equity fund management partnership focused on the biotechnology and pharmaceutical industries. For further information, please visit our website at www.celticpharmaholdings.com.

About the Wellcome Trust

The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust's breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests. Further information can be found at www.wellcome.ac.uk.

About 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. Conventional medicinal chemistry has been unable to manipulate the structure of the naturally occurring compounds into the optimised forms that have the potential to treat human disease. However, Novacta's proprietary technologies allow the structural manipulation and optimisation of activity which is necessary to unlock the potential of this novel and under-exploited class of compounds.

About Clostridium difficile infection ("CDI")

CDI is a disease caused by an overgrowth of, and subsequent toxin production by, Clostridium difficile, an anaerobic spore-forming Gram-positive bacterium of the lower gastrointestinal tract. This overgrowth often occurs subsequent to treatment with antibiotics in the healthcare setting; many antibiotics used for treatment of infections or prophylaxis disrupt the natural gut flora and allow C. difficile to proliferate. The C. difficile toxins cause severe diarrhoea and in some cases can cause life-threatening complications such as ileus, toxic megacolon or gut perforation. Although initial therapy with the oral antibiotics metronidazole or vancomycin usually provides clinical improvement, CDI is notable for the significant number of patients who experience disease recurrence once initial antibiotic treatment is withdrawn. Approximately 20% to 30% of patients who initially respond to treatment experience a clinical recurrence following completion of antibiotic treatment. In patients who have experienced two or more prior episodes of CDI, the risk of further recurrence increases to as much as 50-65%.

 

Please contact with enquiries:

 

Celtic Pharma Holdings Advisors LLP

Stephen Parker

Tel: +44 (20) 7291-5464

                                          stephen.parker@celticpharmaholdings.com

 

Novacta Biosystems Limited

Dr. Mike Dawson

                                                      mike.dawson@novactabio.com

 

Media Contacts:

Citigate Dewe Rogerson

David Dible/Nina Enegren

                                                      Tel: +44 (0) 20 7638-9571

                                                      david.dible@citigatedr.co.uk

                                                      nina.enegren@citigatedr.co.uk