HBO’s hit show The Last of Us depicts the collapse of society in the aftermath of a fungal outbreak that turns infected people into zombies. As an infectious disease specialist and head of a biotech company that specializes in antifungals, I can assure you that there is no reason to worry about a fungus turning you into a zombie. Unfortunately, I can’t offer similar reassurance about the possibility of a significant fungal outbreak. That threat is all too real.
In fact, last month, the CDC warned that the drug-resistant fungus Candida auris is spreading rapidly throughout the United States, with clinical cases tripling from 2019 to 2021. C. auris can cause outbreaks in healthcare settings and kills up to one-third of infected patients.
Every day, more fungi develop resistance to the current arsenal of treatments. And without effective drugs to combat these infections–many of which can be deadly–it’s only a matter of time before we experience a significant outbreak of a fungal or other microbial infection.
In 2019, more people died from antibiotic-resistant bacterial infections than HIV/AIDS or malaria. Fatal fungal infections are on the rise, too, fueled by increased rates of drug resistance. Globally, such pathogens now claim more than 1.6 million lives annually. And unless we develop new treatments, the impact of drug-resistant infections will only worsen in the years ahead. By 2050, resistant infections could kill up to 10 million people annually.
Each breath we take invites fungal spores into our bodies–up to 10 billion per day. The vast majority are completely harmless. And I’m happy to report that the body’s immune system is adept at fending off most of those that pose a threat.
But sometimes the immune system fails, most commonly among people who are immunocompromised or have other health conditions that weaken the body’s ability to fight back.
We have observed a sharp increase in the number of fungal infections reported each year. Over 300 million people worldwide contract a serious fungal infection annually. In the U.S., more than 7,000 people died of a fungal infection in 2021, compared with just 450 recorded deaths in 1969.
Right now, there are just four classes of antifungal treatments available–and few are in the development pipeline.
It wasn’t until last year that the World Health Organization even identified a list of fungal priority pathogens, something the organization started doing for bacterial pathogens in 2017.
The stress on healthcare systems from the COVID pandemic didn’t help matters. The CDC reports that hospitals saw a 15% increase in drug-resistant infections between 2019 and 2020. According to the CDC’s most recent report on Candida auris, cases resistant to echinocandins–the most commonly recommended antifungal to treat C. auris–tripled in 2021 alone.
The good news is that drug researchers aren’t giving up the fight. Our first-in-class novel antifungal is in late-stage investigation and development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients.
There are other promising antifungal candidates in the pipeline, too, including another first-in-class antifungal that is currently under FDA review for the treatment of various fungal infections caused by Aspergillus and other rare molds. But bringing these novel treatments across the finish line and to patients remains extremely difficult.
There is a strong unmet need for new antifungals, and there are too few options for patients whose fungal infections are resistant to current medications. Yet, it’s challenging for small biotech drug developers to get financial support for anti-infective drug development from investors or to recoup development costs.
As a result, many companies in the biotech industry cannot financially sustain an antimicrobial portfolio–and we lose promising research projects in the process.
In late March, my company announced a partnership with GSK to commercialize and further develop our novel antifungal. This agreement enables us to continue our important research, and we consider ourselves very fortunate. It’s a long and uphill battle for small antimicrobial makers to secure funding and spearhead the research and development to bring innovative new therapies to market.
Lawmakers have the opportunity to correct some of the failings of the current system.
There are several promising proposals in the works. The Biomedical Advanced Research and Development Authority, or BARDA, recently announced that it is looking for industry partners to help develop next-generation antifungals that treat high-priority infections.
In Congress, lawmakers could spark antimicrobial development by advancing the PASTEUR Act, legislation that would create a subscription-style contracting model between the federal government and drug developers. Essentially, the government would pay a set upfront amount for access to however few or many doses of a novel antimicrobial product needed in government programs such as Medicare. That would ensure patients have access to the treatments they need while guaranteeing drug developers a return on the investment required to bring the next generation of antimicrobials to patients.
The zombies in The Last of Us are thankfully fictional. But the threat of deadly fungal outbreaks is frighteningly real. Policymakers can’t afford to wait any longer to spur more attention to antifungal research and development.
David Angulo, M.D., is an infectious disease specialist and the president and CEO of the biotechnology company SCYNEXIS.
Read the full op-ed in Fortune.