03:19pm Monday 20 November 2017

New antibiotic ‘safe and well tolerated’ in phase I clinical trial

The experimental drug – NVB302 – is being developed by Novacta Biosystems with support from a Strategic Award from the Wellcome Trust.

C. difficile is a hospital-acquired infection that causes severe diarrhoea and can be fatal, particularly for the elderly and people with weak immune systems. Few of the antibiotics that are currently available are effective against the infection and drug resistance is a growing threat.

One of the biggest complications of antibiotic therapy is that it kills the body’s own ‘good’ bacteria in the gut, which gives the disease-causing C. difficile more room to grow. This means that a significant number of patients, around 20 per cent to 30 per cent, experience disease recurrence once initial antibiotic treatment is withdrawn. In patients who have experienced two or more prior episodes of C. difficile infection, the risk of further recurrence increases to as much as 50-65 per cent.

NVB302 is a member of a new class of antibiotics known as the type B lantibiotics. Laboratory studies have shown it to be effective against all strains of C. difficile tested, without affecting the healthy bacteria that are normally found in the gut.

In the phase I trial, 64 healthy volunteers were given ascending doses of NVB302. The new antibiotic was safe and well tolerated at all doses tested. Commenting on the results, Mike Dawson, Chief Scientific Officer at Novacta, said: “We are very pleased to announce the completion of our phase I study. The study clearly indicates that NVB302 warrants further investigation as an agent for treatment of C. difficile infection.”

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 that combat the problem while helping to preserve the normal gut flora.”

The next step in the development of this experimental drug will be to show that it is effective at killing C. difficile in patients in phase II and III clinical trials.

Combating infectious disease is one of the Wellcome Trust’s five strategic research challenges.

Image: Clostridium difficile. Credit: David Goulding, Wellcome Trust Sanger Institute, Wellcome Images.

Wellcome Trust, Gibbs Building, 215 Euston Road, London NW1 2BE, UK T:+44 (0)20 7611 8888

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