First new antibiotic in 50 years to tackle superbug
The drug, which targets one of the bacteria considered to pose the biggest threat to human health, has been hailed as an 'exciting' development in the fight against antibiotic resistance.
On Monday, Roche, the Swiss pharmaceutical giant, announced that it will take zosurabalpin into the third and last phase of testing on humans.
It is the first drug in five decades to show promise of tackling Acinetobacter baumannii, a pathogen which is described as a 'priority' by the World Health Organisation and an 'urgent threat' by the Centers for Disease Control and Prevention, the US national public health agency.
The drug-resistant bacteria disproportionately impact patients who are in the hospital, causing infections such as pneumonia and sepsis.
It is estimated that between 40 and 60 per cent of infected patients, many of whom are immunocompromised because of conditions such as cancer, die as a result of the bug.
One of the reasons it is so difficult to treat is that it has a double-walled 'membrane' protecting it from attack, so it is difficult to get drugs into it and to keep them in, experts say.
Zosurabalpin, which has been developed alongside researchers at Harvard University, targets the 'machine' which stops the outer membrane from forming properly.
It works differently to all existing antibiotics and it is hoped that it could lay the foundations for future drugs.
Michael Lobritz, global head infectious diseases at Roche, said: 'Our goal is to contribute new innovations to overcome antimicrobial resistance, one of the biggest infectious disease challenges to public health.'
The phase-three trial, which it is hoped will start later this year or in early 2026, will look at around 400 patients with a carbapenem-resistant Acinetobacter Baumannii (CRAB) infection who will either receive zosuarbalpin or the current standard of care.
It is hoped that the drug will be approved by the end of the decade.
Larry Tsai, senior vice president and global head of immunology and product development at Genentech, a unit of Roche, said that the drug-resistant bacteria 'are present in every country of the world' .
He said that 'the innovative biology involved in this research could potentially reveal new insights into the structure of bacterial membranes, possibly leading to the discovery of new antibiotics in the future'.
Pharmaceutical companies, including Roche, have in the past been unwilling to pursue new antibiotics because of a difficult market in which the drugs are used sparingly to try and avoid resistance.
However, the UN has warned that if nothing is done to address the issue, drug-resistant diseases could cause 10 million deaths each year by 2050 and cause a worldwide financial crash.
Dr Alistair Farley, scientific lead at the Ineos Oxford Institute, has welcomed zosurabalpin as an 'exciting development' for the field.
'There is an urgent unmet clinical need to develop new antibiotics against priority pathogens such as CRAB where antimicrobial resistance is a major concern,' he said.
Dr Farley added that it 'may provide a route to the development of new drugs'.
Studies showing that it worked 'extremely well' in test-tubes and mice were published in the journal Nature earlier this year.
Prof Laura Piddock, scientific director of the Global Antibiotic Research and Development Partnership, said at the time that it provided 'definite hope' for other hard-to-treat infections.
'What is exciting about this discovery is that one of the building blocks that are part of the outer part of this bacterial cell is disrupted by this new drug,' Prof Piddock said.
Antimicrobial resistance was declared by world leaders to be 'one of the most urgent global health threats' at the UN General Assembly earlier this year.
The declaration committed members to establish independent panels on antimicrobial resistance, as many have done for climate change, and to reduce deaths linked to resistance by 10 per cent by 2030.
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