Drug Development

Investigators signal thumbs-up for antibiotic, prep an FDA pitch for OK

Investigators for Shionogi say they’re prepping an FDA application for a new antibiotic after rounding up solid comparison data in a pivotal study.

Cefiderocol (or S-649266) hit its marks for a Gram-negative study, proving non-inferior to imipenem/cilastatin when used to treat a complicated urinary tract infection.

The efficacy data on Cefiderocol was good: 72.6% of the new antibiotic arm was cured compared to 54% of the imipenem arm. And fewer patients experienced a serious adverse event: 4.7% versus 8.1%.

This antibiotic adopted a Trojan Horse strategy to puncture the cell membranes of pathogens. It binds to ferric acid and is then smuggled in by bacterial iron transporters used to feed bacteria.

“Unlike most studies, this cUTI study was designed to include patients that are more difficult to treat.  The data clearly demonstrate that cefiderocol will be an important option for serious Gram-negative infections,” said Dr. Tsutae Den Nagata, the CMO at the Japanese pharma company, which is based in Osaka with R&D operations in New Jersey.

Despite a rising tide of drug-resistant pathogens and years of warnings about the need for new development, there are only a handful of biotechs focused on this field. Achaogen is one, while the gRED and pRED arms at Roche are both engaged in their own programs. Many big pharmas bowed out of the field, complaining the business was too low margin to warrant the investment.

It’s not easy developing antibiotics, as Cempra proved with the recent rejection it experienced for solithromycin.


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