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GSK takes new-class antibiotic into phase 3 for serious infections

Could provide a much-needed option for treatment-resistant infections

GSK

GlaxoSmithKline has started two phase 3 trials of the first drug in a completely new class of antibiotic that could provide a much-needed option for severe, resistant infections.

The new drug, called gepotidacin, is being developed initially to treat uncomplicated urinary tract infection (UT) and urogenital gonorrhoea, two infections that GSK says have not seen any new oral antibiotics for 20 years.

The EAGLE-1 trial will enrol 600 patients with gonorrhoea, while EAGLE-2 has a target population of 1,200 people with UTIs which are confined to the lower urinary tract.

Gonorrhoea is the second-most common sexually-transmitted infection (STI) around the world, affecting millions of people every year, and fears are rising of so-called super-gonorrhoea that is resistant to the recommended first-choice treatment – a combination of azithromycin and ceftriaxone.

Last year, a UK man became the first patient in the UK to diagnosed with super-gonorrhoea and was fortunate to eventually be cleared of the infection using intravenous ertapenem, a last-line therapy, raising fears that in time strains of gonorrhoea could emerge that are completely untreatable.

Of all the STIs, gonorrhoea is the most antibiotic-resistant, according to the World Health Organisation (WHO). Because it works in a different way to any currently-approved antibiotic, gepotidacin could sidestep bacterial resistance mechanisms.

EAGLE-1 will compare gepotidacin – a triazaacenaphthylene bacterial topoisomerase inhibitor developed in collaboration with US federal agencies – to the azithromycin/ceftriaxone regimen, while EAGLE-2 will use standard UTI therapy nitrofurantoin as the active control drug. Results are expected in 2021.Hal Barron

“We believe this drug has the potential to transform the treatment landscape for patients with [these infections] who currently have limited therapeutic options,” commented Hal Barron (pictured left), GSK’s head of R&D.

Phase 2 testing has revealed that gepotidacin was 95% effective in eradicating uncomplicated gonorrhoea, and also worked at two of three doses tested against acute bacterial skin and skin structure infections (ABSSSI).

Rates of the STI are on the rise in the US, having been at historic lows just a few years ago, according to a Centres for Disease Control and Prevention (CDC) report published earlier this month which said there were almost 600,000 cases last year, a 63% increase on 2014. That pattern is repeated around the world, says the WHO.

If gepotidacin is shown to be effective in the phase 3 programme, a big question is how it will be used commercially.

Pharma companies have exited antibiotic research in droves, put off by the paradox that lies at the heart of antimicrobial drug development: the newest, most effective drugs are typically kept in reserve for infections that don’t respond to older agents. That means they are used the least, delivering little payback for the cost of their development.

That has resulted in no entirely new class of antibiotics since the 1980s, and prompted calls for new payment systems to disconnect payments for drugs from the volume sold. The UK, for example, plans to trial a subscription-style payment model with pharmaceutical companies paid upfront for access to drugs based on their usefulness to the NHS – a model that has been welcomed by GSK.

Article by
Phil Taylor

29th October 2019

From: Research

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