An antibiotic candidate developed by the Irish company Iterum Therapeutics has failed to meet the main goal of a phase III trial, a blow for efforts to meet the challenge of global antibiotic resistance.
Iterum Therapeutics’ drug sulopenem was tested in a phase III trial that recruited 674 patients suffering from complicated intra-abdominal infections. These are the second most deadly type of infection for patients in intensive care. The aim of the trial was to show that sulopenem was as good at treating the infections as ertapenem, an approved antibiotic for the condition.
According to the trial results, sulopenem treated the infection in almost 5% fewer patients than ertapenem. The drug statistically failed to show that it was as good as its approved counterpart.
Despite this disappointing result, Iterum is holding out hope for an FDA approval. The company pointed out that the miss was a narrow one, and it will await results from two other phase III trials of the antibiotic in patients with infections of the urinary tract. The results are expected in early 2020.
Abdominal and urinary tract infections that are resistant to first-line antibiotics are often treated with injected antibiotics like carbapenems or harsh oral antibiotics like fluoroquinolones. Iterum licensed sulopenem from Pfizer in 2015 because it saw the potential for the drug to treat drug-resistant abdominal and urinary tract infections in an oral form without the side effects of fluoroquinolones.
Iterum’s phase III trial failure is a setback for those hoping for the approval of new antibiotics on the market. There is a growing crisis of new strains of bacteria becoming resistant to existing antibiotics and big pharma companies tend to see developing antibiotics as unprofitable due to their limited lifespan and sparing use in healthcare. To tackle this problem, governments like that of the UK are increasingly implementing policies to hurry up the development of new treatment options.
While Iterum Therapeutics’ antibiotic is one of the most developed of the new generation of antibiotics, a number of companies in Europe have antibiotic candidates in phase III including the big pharma GSK and the UK biotech Summit Therapeutics.
In addition to small molecule antibiotics, there are companies developing other antibacterial treatments to tackle the antibiotic resistance crisis. For example, the French biotech Pherecydes Pharma is developing bacteria-hunting viruses called bacteriophages to bypass antibiotic resistance.
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