Getting new antimicrobials to patients combatting drug resistance

On March 23, 2024, the Access to Medicines Foundation published a report analyzing how pharmaceutical companies can introduce new, promising antimicrobials to patients with antimicrobial-resistant superbugs.

"We have a small but effective arsenal in the race to combat drug-resistant infections. The difference between us winning or losing this race depends on how companies enable access to people living on the frontlines of drug resistance,” said Jayasree K. Iyer, CEO of the Access to Medicine Foundation, in the foundation’s press release.

The report was released under the foundation’s Antimicrobial Resistance program, focusing on mobilizing pharmaceutical companies to address ongoing drug-resistant infectious disease management challenges.

The organization acknowledges that despite the limited research efforts into developing new antibiotics, the available tools and research may be critical to addressing the global antimicrobial resistance crisis.

Among these tools are four innovative, late-stage research and development projects that the foundation analyzed.

The first is gepotidacin, a new class of chemical antibiotics developed by GSK to address uncomplicated urinary tract infections (uUTIs) and uncomplicated urogenital gonorrhea. According to the report, GSK plans to submit a new drug application to the FDA later this year for gepotidacin to treat uUTIs and another application in 2025 for the drug to treat gonorrhea.

F2G is researching olorofim to target invasive fungal infections, including Aspergillus fumigatus. Meanwhile, Innoviva is researching zoliflodacin for uncomplicated gonorrhea and plans to submit an application to the FDA in the coming year.

Finally, Venatorx is researching cefepime-taniborbactam, a beta-lactam and beta-lactamase inhibitor (BL/BLI) combination antibiotic, to treat complicated urinary tract infections (cUTIs).

The report also analyzed Pfizer’s recently approved drug, aztreonam-avibactam, which can treat complicated intra-abdominal infections (cIAI), hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP), cUTIs, and other diseases.

After reviewing these case studies, the Access to Medicine Foundation discovered four key points.

• There is a lack of concrete registration plans in low- and middle-income countries.
• Research planning overlooks affordability and stewardship in low- and middle-income countries.
• The presence of pediatric trials before market approval bodes well for treatment in children.
• While partnerships improve scalability, other tools that broaden access and stewardship are underused.

"Tackling the sheer scale and pace of drug resistance is a complex global health issue that will require action from pharmaceutical companies across several areas. This includes providing appropriate access and implementing stewardship measures to safeguard the effectiveness of innovative antimicrobials. Failure to do this will limit efforts to tackle drug resistance,” added Marijn Verhoef, Director of Operations and Research at the Access to Medicine Foundation.