The development of new antibacterial treatments is insufficient to address the growing threat of antibiotic resistance, according to the World Health Organization’s annual report. The 2021 report describes the antibacterial clinical and preclinical pipeline as stagnant and far from meeting global needs. As of 2017, only 12 antibiotics have been approved, 10 of which belong to existing classes with established mechanisms of antimicrobial resistance (AMR).
“There is a big gap in the discovery of antibacterial treatments and even more so in the discovery of innovative treatments.” said Dr. Hanan Balhi, WHO Assistant Director-General for AMR. “This poses a serious challenge to overcoming the escalating pandemic of antimicrobial resistance and makes each of us increasingly vulnerable to bacterial infections, including the simplest infections.
According to WHO annual analyzes, in 2021 there were only 27 new antibiotics in clinical development against priority pathogens compared to 31 products in 2017. In the preclinical phase – before clinical trials could begin – the number of products remained relatively constant in the last 3 years.
More broadly, the report describes that of the 77 antibacterial agents under clinical development, 45 are “traditional” direct-acting small molecules and 32 are “non-traditional” agents. Examples of the latter are monoclonal antibodies and bacteriophages, which are viruses that can kill bacteria. Because antibiotics already have a limited life before drug resistance emerges, non-traditional approaches offer new ways to deal with infections from antimicrobial-resistant bacteria from different angles, as they can be used complementary and synergistically or as an alternative to established therapies. .
Barriers to new product development include the long road to approval, the high cost, and the low success rate. It currently takes approximately 10-15 years for a candidate for an antibiotic to move from the preclinical to the clinical stage. For antibiotics in existing classes, on average, only one in 15 preclinical drugs will reach patients. For new classes of antibiotics, only one in 30 candidates will reach patients.
Of the 27 antibiotics in the clinical process that address priority pathogens, only six meet at least one of the WHO’s innovation criteria. The lack of innovation is rapidly undermining the effectiveness of the limited number of new antibiotics reaching the market. On average, resistance is reported for most new agents 2-3 years after entering the market.
“Time is running out to anticipate antimicrobial resistance, and the pace and success of innovation is far below what we need to ensure the advances of modern medicine against age-old but devastating conditions such as neonatal sepsis.” said Dr. Haileyesus Getahun, director of the WHO’s Global Coordination AMR. Approximately 30% of newborns with sepsis die from bacterial infections resistant to first-line antibiotics.
The COVID-19 pandemic has also hampered progress, delayed clinical trials and distracted already limited investors. Much of the innovation in antibiotics is driven by small and medium-sized companies struggling to find investors to fund the late stage of clinical development until approved by regulators. It is not uncommon for companies to suspend product development for several years in the hope of securing funding to continue development at a later stage or for the product to be purchased by another company. They go bankrupt a lot.
Therefore, urgent and coordinated R&D investment by governments and the private sector is needed to accelerate and widen the antibiotic pipeline, especially those that may have an impact in low-resource environments that are most affected by AMR. . States must work together to find sustainable solutions and incentives for research, development, innovation and to create a viable antibiotic ecosystem.