Shionogi reports positive results for cefiderocol in pneumonia

pharmafile | October 14, 2019 | News story | Sales and Marketing  

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

The new trial, called APEKS-NP, has been carried out in nosocomial (hospital-acquired) pneumonia, and shows that Shionogi’s investigational 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.

Tsutae “Den” Nagata, Chief Medical Officer at Shionogi, said: “Data from APEKS-NP provide meaningful evidence that cefiderocol has the potential to be an effective treatment option for severely ill hospitalised patients with pneumonia.

“In this trial, nearly 60 percent of patients were ventilated and approximately 33 percent experienced treatment failure of prior therapy. Recently, several new antibiotics have been introduced to address some carbapenem-resistant infections, but they do not address all resistant Gram-negative pathogens.

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

“Carbapenem resistance is a growing problem in the U.S. and around the world, with increasing infections due to strains that are resistant to most or all currently available antibiotics. Patients with serious infections caused by resistant Gram-negative pathogens are facing a most serious challenge with high morbidity and mortality rates.

It is estimated that by 2050 more than 10 million people will die every year due to antibiotic resistant infections, a mortality that is higher than cancer, unless new effective antibiotics are developed.

Nik Kiran

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