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Shionogi trumpets pneumonia data for new antibiotic cefiderocol

The drug is already under regulatory review in the US and Europe

Shionogi

Shionogi has positive data from a trial of cefiderocol, its novel cephalosporin antibiotic that is already under regulatory review in the US and Europe for serious Gram-negative bacterial infections.

Cefiderocol has already been filed for approval as a later-line therapy for serious Gram-negative infections in Europe, as well as for the narrower indication of complicated urinary tract infections (cUTIs) caused by Gram-negative organisms in the US, where a verdict is due from the FDA next month.

The new APEKS-NP trial has been carried out in nosocomial (hospital-acquired) pneumonia, and shows that Shionogi’s drug worked as well as a high dose of the older antibiotic meropenem in reducing all-cause mortality at 14 days.

Cefiderocol also matched meropenem on secondary endpoints such as eradicating the infection at the ‘test of cure’ stage – when a decision is made whether to discontinue antibiotic treatment – and all-cause mortality at 28 days.

The data show that cefiderocol “has the potential to be an effective treatment option for severely ill hospitalised patients with pneumonia”, said Shionogi’s chief medical officer Tsutae ‘Den’ Nagata.

He also pointed out that the patients were very ill, with 60% requiring mechanical ventilation and a third failing prior rounds of antibiotic treatment. After 14 days, around 12% of both meropenem and cefiderocol treatment groups had died, rising to 21% apiece at day 28.

Hospital-acquired pneumonia is often particularly challenging because the pathogens that cause it have often developed resistance to multiple drugs, thanks to the widespread use of antibiotics in clinics.

Carbapenems such as meropenem, ertapenem, imipenem and doripenem are normally reserved for serious infections caused by drug-resistant Gram-negative bacteria, but rates of resistance to these drugs are on the rise and pose a serious threat to public health.

By 2050, it is estimated more than 10 million people will die every year of antibiotic-resistant infections, a mortality rate higher than cancer, unless the pace of new antibiotic development can be stepped up.

Cefiderocol is a siderophore cephalosporin with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens, including multi-drug-resistant strains, says Shionogi.

“Recently, several new antibiotics have been introduced to address some carbapenem-resistant infections, but they do not address all resistant Gram-negative pathogens,” said Nagata.

“Clinicians are in urgent need of novel therapeutic approaches to overcome the multiple resistance mechanisms that make these strains so difficult to treat.”

Merck & Co/MSD has also set its sights on carbapenem-resistant Gram-negative pathogens with a Recarbrio, a new combination of its older Primaxin (imipenem/cilastatin) antibiotic plus a new beta lactamase inhibitor called relebactam that restores susceptibility to imipenem in resistant strains.

Article by
Phil Taylor

11th October 2019

From: Research

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