Novacta Receives 3.5 Million Pounds Strategic Translation Award From The Wellcome Trust To Target C.difficile Infections, UK

Main Category: MRSA / Drug Resistance
Article Date: 15 Jan 2008 - 1:00 PDT

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Novacta Biosystems, a UK-based anti-infective therapeutics company, announces that the Wellcome Trust, the UK's largest medical research charity, has awarded it £3.5 million as part of the Trust's Strategic Translational Award programme. Novacta will use the award to progress development of a drug which, it is hoped, will help combat hospital-based Clostridium difficile (C.difficile) infections.

C. Difficile infections (CDIs) are a growing and serious problem and have, for example, been associated with twice as many deaths in UK hospitals last year as MRSA. Cases of C.difficile infections, which occur in the lower digestive tract, rose by 22 per cent in the past year and affected more than 15,500 people over 65 in the first quarter of 2007. New anti-infective drugs are needed to target C.difficile without depleting other beneficial bacteria in the gut.

Novacta is developing novel, naturally-derived products known as 'lantibiotics' as potential drugs for treating hospital acquired infections caused by C.difficile. Early preclinical data show promise for an effective treatment for CDI, acting selectively to kill C.difficile with less disturbance of normal gut bacteria than seen with existing drugs. Novacta will use the Wellcome Trust Strategic Translational award to progress its preclinical drug candidates into human clinical studies.

Dr Ted Bianco, Director of Technology Transfer at the Wellcome Trust, said "It is ironic that the current rise in C.difficile infections owes much to the widespread use of broad spectrum antibiotics. We need to be smarter in how we deploy our existing medicines and how we develop new treatments. Novacta should be applauded for its efforts to move away from carpet bombing our microbial flora in favour of precision targeting of the C.difficile bacterium."

Dr Mike Dawson, Novacta's Chief Scientific Officer, commented, "We are encouraged by early preclinical results which show potential for a much more selective approach to treat CDI. The Trust's support will enable us to complete preclinical development and to conduct a Phase I clinical trial to establish safety and tolerability in humans."

Dr Tony Sedgwick, Novacta's Chief Executive Officer, commented, 'We are delighted that the Wellcome Trust has recognised our work in the area of lantibiotic drugs for the treatment of CDI. We are now positioned to evaluate the clinical potential of our programme, while we continue to build our product pipeline for other therapeutic indications."

About Novacta

- Novacta is a UK-based biotechnology company that specialises in the discovery and development of potential treatments for infectious diseases using a class of naturally occurring compounds called lantibiotics

- Novacta's proprietary, patented technologies are in the fields of 'pathway engineering' (in which the pathways used by microorganisms are harnessed and exploited) and 'biotransformations' (in which natural catalysts called enzymes are used to perform otherwise complex chemistry in a cleaner and more efficient way than some traditional methods). These technologies are applied to manipulate the structure of natural lantibiotics and optimise them for use as therapeutic agents in areas of unmet medical need

- Novacta's technologies have given rise to a number of potential drug candidates, including those in the C.difficile programme. Other programmes include one targeting methicillin-resistant Staphylococcus aureus (MRSA) infection, and others targeting antiviral and oncology indications

- Novacta also uses its technologies to provide new specialist process and compound development capabilities to a number of companies in the pharmaceutical, fine chemicals and biofuels industries; and Novacta has established a number of revenue generating alliances with other companies

- Novacta was established in 2003 and currently employs around 25 people; it recently moved to larger premises as part of BioPark Hertfordshire in Welwyn http://www.novactabio.com

About The Wellcome Trust

- The Wellcome Trust is the largest charity in the UK. It funds innovative biomedical research, in the UK and internationally, spending around £500 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing.

http://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 Clostridium difficile and MRSA, and in skin infections such as impetigo and acne

- 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

- The most well known lantibiotic is nisin, which has a long history of use as a food preservative

About Clostridium.difficile (C.difficile)

- C. difficile is a spore-forming, anaerobic bacterium that is normally present in the intestine of up to 3 per cent of healthy adults and 66 per cent of infants

- C.difficile rarely causes problems in healthy individuals as it is kept in check by the normal bacterial population of the intestine. However, the broad spectrum antibiotics commonly used therapeutically or prophylactically in hospitals disturb the balance of bacteria in the gut, allowing C. difficile to multiply rapidly and produce toxins which cause C. difficile-associated infections (CDI), pseudomembranous colitis and, in extreme cases, death

- CDI is the most important cause of hospital-acquired diarrhoea

- There is much data* to suggest that the recognised incidence of CDI has increased dramatically during the past decade. Thus the number of deaths involving C. Difficile infections in US hospitals has more than doubled since 1998 and figures for the UK suggest similar trends (*Data from the National Statistician, Parliamentary Publications, 16 January 2007)

- In addition to general increases of CDI incidence, the spread of the highly toxigenic and aggressive strain C. difficile Ribotype 027 has caused significantly increased mortality, particularly in elderly patients with other underlying diseases

- During the past few years there has been a growing awareness amongst clinicians that C. Difficile poses a significant threat. Many hospitals now place greater priority on isolating C. Difficile infected patients than those with other infections such as MRSA. In addition, public awareness is also rapidly increasing, driven by many publications in the lay press and other media

The Wellcome Trust