One in six infections worldwide is now resistant to first-line antibiotics, making antimicrobial resistance (AMR) a major global health threat. Despite an extremely challenging commercial landscape, a handful of bold startups continue to innovate in this space, but can they turn the tide?
Microorganisms that develop AMR were directly responsible for 1.27 million global deaths in 2019, while contributing to 4.95 million deaths, more than HIV/AIDS and malaria combined. Analysis in The Lancet predicts that deaths could rise to 39 million by 2050 without action.
Yet commercial incentives for antibiotic innovation remain broken. New antimicrobials are deliberately held in reserve to preserve effectiveness, so sales stay low. Prices are modest, treatment courses short, and reimbursement still volume-based. As a result, only 32 antibiotics are in clinical development for WHO-priority pathogens (compared to over 1,600 in oncology), just 12 of them with novel mechanisms.
Transnational bodies are taking the issue seriously – in 2024 the UN pledged to cut AMR deaths by ten percent by 2030 while this year the WHO launched an updated AMR dashboard tracking across 110 countries. In the EU, several R&D schemes to support the development of these drugs have been launched, although thus far with limited effectiveness
And national governments are responding too. For instance, the Swiss Federal Council’s ‘Strategy against Antimicrobial Resistance (StAR),’ first launched in 2016, has successfully reduced antibiotic consumption and AMR in Switzerland. “This strategy contributed to the relatively low levels of AMR in Switzerland compared to our neighbouring countries,” explains Daniel Roth, a member of the management board and consultant at Menarini, which was the industry sponsor for the last three antibiotics launched in Switzerland.
On the commercial side, the United Kingdom launched a subscription model guaranteeing GBP 25 million per year for 15 years for new antibiotics, while Italy now allows for premium pricing of certain antibiotics equivalent to oncology therapies.
While Switzerland is yet to implement such models, it does play host to a cadre of bold companies stepping up to innovate in a space long-ago exited by their Big Pharma counterparts. For example, OM Pharma targets prevention through bacterial lysates; Resistell and Abionic deliver rapid diagnostics; Basilea Pharmaceutica markets hospital-grade antibiotics; and BioVersys, spun out of ETH Zurich, focuses on antimicrobials for immediately life-threatening infections.
Off the back of a recent Swiss Stock Exchange IPO and backing from the USD one billion AMR Action Fund, BioVersys is advancing its lead candidate for severe hospital infections into Phase III clinical trials this year.
CEO and Founder Marc Gitzinger explains that there is an urgent medical need in this space, as around 50 percent of patients suffering from conditions like severe hospital-acquired pneumonia, bloodstream infections, and tuberculosis meningitis demonstrate resistance to current standard-of-care treatments.
“Unlike many other conditions where treatment initiation can be delayed by days or weeks, infectious disease management requires immediate intervention,” says Gitzinger, a co-founder of the BEAM Alliance, a 70-member biotech industry coalition which advocates for modern reimbursement methodologies for antibiotics in Europe. “Statistically, every six-hour delay in appropriate therapy increases mortality risk by five to ten percent.”
This situation is set to worsen in the coming years. “Currently, we still have many older antibiotics that work effectively in many patients,” begins David Veitch, CEO of Basilea, a Basel-based biotech and the BEAM Alliance’s largest member, which has been able to commercialise (and turn a profit) with its own antimicrobial medicines. “The issue is the remaining instances when these treatments fail, which is increasing as bacterial resistance increases. Bacteria adapt quickly, and if they become resistant to our existing treatments, we could face a similar situation to COVID.”
“Although there are a lot of discussions about AMR, there is still not enough concrete action,” states Veitch, who highlights demonstrating superiority over existing treatments as the key component to his company’s commercial success in the notoriously challenging antimicrobial space. He warns, “We need to focus on real steps and meaningful incentives to encourage more companies to invest in this area.”
Whether global reimbursement systems evolve quickly enough to sustain such innovation remains uncertain. But with what was once called a “silent pandemic” now in full view and growing, Swiss innovation may prove pivotal.
“These bacterial strains survive existing approved therapies by definition – medical needs will continue expanding,” concludes Gitzinger. “These important therapeutics represent essential medicines for global health security.”