The World Health Organization (WHO) yesterday published blueprints to guide development of urgently needed new antibiotics for three types of bacterial infections.
The three new target product profiles (TPPs) focus on new antibiotics for:
Severe multidrug-resistant gram-negative infections caused by carbapenem-resistant Enterobacterales, Acinetobacter baumannii, and Pseudomonas aeruginosaSevere antibiotic-resistant gram-positive infections in immune-suppressed and critically ill patients, with a focus on Enterococcus faeciumCommunity-acquired and health care-associated bacterial meningitis
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The purpose of TPPs is to help accelerate the drug development process—and establish priorities for researchers, funders, and developers—by outlining the desired characteristics for new antibiotics. They describe the intended use, target populations, mechanism of action, and route of administrations, and define clear targets for quality, safety, efficacy, pharmacokinetics, access, and affordability.
“They are intended to facilitate the most expeditious development of novel antibiotics addressing the greatest and most urgent public health needs posed by antimicrobial resistance (AMR),” the WHO said.
Antibiotic development not keeping up with resistance
All three of the targeted infection types are currently treated with antibiotics that are becoming less effective as drug resistance rises, and there are few candidates in the antibiotic pipeline to provide new treatment options. WHO officials say the aim of the three new TPPs is to align antibacterial product development with the WHO’s bacterial priority pathogens list, prioritize infections that lead to high morbidity and mortality, and incentivize and de-risk antibiotic development.
“The scientific community has developed and approved new antibiotics in recent years. This is good, but unfortunately not sufficient to catch up with evolving drug-resistance bacteria, especially against those of greatest concern,” Yvan Hutin, MD, PhD, director of antimicrobial resistance at the WHO, said in a press release. “We need a reliable pipeline with new antibacterial agents that are innovative, affordable, accessible to all those who need them.”