GSK maintains lead in antibacterial and antifungal R&D to target priority pathogens

As antimicrobial resistance spreads, new medicines and vaccines that target priority bacterial and fungal pathogens are needed urgently. Infectious diseases projects are risky for companies due to the scientific challenges of discovering new antibiotics, the complexities of development and the limited economic attractiveness of the market.

The Benchmark expects large research-based pharmaceutical companies to continue engaging and investing in R&D that targets priority bacterial and fungal pathogens. Especially urgent is the need to develop products that offer a better chance of lasting effectiveness by operating in novel ways. To determine how ‘novel’ a medicine or vaccine is, the Benchmark uses four criteria defined by the World Health Organization (these are: new chemical class; new target; new mode of action; and/or absence of cross-resistance).

Why does GSK lead in R&D?

Of the eight large research-based pharmaceutical companies evaluated, GSK invests the largest absolute amount in R&D. It leads in R&D targeting the priority bacteria and fungi in scope, with a total of 31 projects in the pipeline (up from 27 in 2020), more than half (19) are in discovery and preclinical stages. Of all companies in scope, GSK’s pipeline is the biggest, addresses more pathogens designated as ‘critical’ and/or ‘urgent’ threats (by the WHO and/or US Centers for Disease Control) than others, has the most vaccines projects, and is developing the largest number of innovative treatments. By investing in innovation and with a high proportion of projects at an earlier (riskier) stage, GSK shows best practice.

Six of eight companies in scope for the R&D Research Area are developing candidates that target pathogens in the ‘critical’ and/or ‘urgent’ threat categories, including 18 that are in clinical-stage development or are recently approved products. GSK has the most, followed by Pfizer and Shionogi. Since 2020, these companies have increased their number of critical and/or urgent priority pathogen projects.

GSK is developing gepotidacin, a late-stage candidate that is considered a new chemical class, with a new mechanism of action, which targets E. coli and N. gonorrhoeae. The latter is a pathogen that experts warn could become resistant to all currently available antibiotics. The company also has an anti-tuberculosis agent considered a new chemical class, with a new target, new mode of action and no known cross-resistance to other antibacterial classes.

Reflecting its commitment to prevent infections and reduce society’s dependence on antibiotics, GSK dedicates more than half of its R&D pipeline to vaccine projects. Of the six companies active in vaccine R&D, GSK reports by far the most projects (16), 13 of which are innovative and three that are adaptive. Both GSK and Pfizer (with the second highest number of vaccine projects) have candidates in clinical development to prevent C. difficile, one of the most common causes of hospital-acquired infections, with an increasing incidence worldwide.

Next steps

Since 2018, the Benchmark has recognised GSK as being at the forefront of antimicrobial R&D. The company supports the AMR Action Fund along with six other companies assessed by the Benchmark (Johnson & Johnson, MSD, Novartis, Pfizer, Shionogi and Teva), and it collaborates on a diverse range of projects with partners and funders including the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the Bill & Melinda Gates Medical Research Institute, the TB Alliance, Wellcome Trust and the National Institutes of Health (NIH).

In the last 20 years, investment in innovation for antibacterial medicines and vaccines has declined. The Benchmark expects all large research-based pharmaceutical companies to continue to engage and invest in R&D to combat the spread of AMR, whether through private funding or by joining consortia with public funding, and/or through discovery programmes, in-licensing or acquisitions. Companies must find new ways to develop and commercialise novel products that can remain effective, and ensure they reach the populations that need them.