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<i>Manica Balasegaram is executive director of the Geneva-based Global Antibiotic Research &amp; Development Partnership.</i>

Zoliflodacin is remarkable, but I don’t mean that for the obvious reasons.

Yes, it is<a href="https://pubmed.ncbi.nlm.nih.gov/32329999/" target=_blank> the first</a> of a new kind of antibiotic. And it could soon become the first new antibiotic <a href="https://www.nature.com/articles/d41586-023-03448-x" target=_blank>in decades</a> to treat gonorrhea, working against all the strains of the bacteria that are resistant to the drugs we have. Plus zoliflodacin can be swallowed. And it takes just one dose to work.

All of that is exciting. But to me the most remarkable thing about zoliflodacin is how it came to market: The heavy lifting of getting it from lab to clinic was paid for and run by a nonprofit, not by a pharmaceutical giant.

This new model for putting the next generation of antibiotics into doctors’ and patients’ hands offers hope. Infections that can’t be treated with antibiotics now are associated with <a href="https://www.cdc.gov/drugresistance/national-estimates.html" target=_blank>nearly 5 million deaths a year</a>. When I was a doctor in Africa and Asia early in my career, I saw firsthand the suffering and stigma caused by untreatable infections and realized there had to be a better way forward.

The problem is one of market failure. At the same time as more and more bacteria have become resistant to the drugs available, the global pipeline in new treatments has dried up: Antibiotics are a high-risk, low-reward business. Experts in global public health have been sounding the alarm about this crisis of antimicrobial resistance for decades.

Enter public and philanthropic funding. Most investments by governments and charities aimed at tackling drug resistance <a href="https://globalamrhub.org/wp-content/uploads/2020/11/GlobalAMRHubReportDD.Nov2020.pdf" target=_blank>go toward the basic research</a> needed to identify potential new drugs — preclinical lab work and early-stage clinical trials in people.

This foundational work is necessary, but it is not sufficient. Most of the drug candidates that result don’t make it to the patients who <a href="https://pubmed.ncbi.nlm.nih.gov/30325963/" target=_blank>need them the most</a>.

Why? Because to get a drug onto pharmacists’ shelves takes vast amounts of <a href="https://wellcome.org/news/why-is-it-so-hard-develop-new-antibiotics" target=_blank>time and money</a>. Companies have to bet on profitability, not public health need — and there just aren’t big bucks to be made in antibiotics. Especially not in antibiotics that can treat the diseases that are most common in poor countries.

Gonorrhea is a case in point. Worldwide, there are 82 million cases of this sexually transmitted infection each year, and the total is rising. In 2021, there were <a href="https://www.cdc.gov/std/statistics/2021/default.htm" target=_blank>more than 700,000</a> cases in the United States. Without treatment it can cause pain, infertility and arthritis. It can even be life-threatening.

The <a href="https://onehealthtrust.org/news-media/blog/poverty-and-antimicrobial-resistance/" target=_blank>hardest-hit </a>people live in lower-income communities and countries. And gonorrhea is becoming increasingly resistant to the last effective antibiotic. This curable disease could become one of the first to return to being untreatable.

Hence the excitement about zoliflodacin. As with so many other candidate antibiotics, its journey could have ended prematurely in Phase 2 trials, where it showed potential.

Instead, my organization took up the baton. The Global Antibiotic Research &amp; Development Partnership put zoliflodacin through the largest-ever Phase 3 trial for gonorrhea treatment. GARDP funds come from many of the Group of 20 governments, the European Union and philanthropies. Now the drug will go to national regulators, such as the U.S. Food and Drug Administration, for review.

This approach put global public health front and center. For example, the trials were done across different regions and income levels and recruited trial participants who often miss out: women, adolescents and people living with HIV. And the drug was designed to be affordable.

Our partnership agreements are different, too. They de-risk the commercial process for donors and industry partners by carrying out clinical trials and supporting regulatory submission. In return, GARDP gets a license to distribute zoliflodacin to two-thirds of the world. This allows us to contract with manufacturers, including of generics, to take the treatment to people in low- and middle-income nations.

The public-private model makes best use of public money by getting stakeholders to work together from the get-go: scientists, industry, manufacturers, governments, donors and civil society. A similar approach is being used to combat malaria and other neglected diseases through the work of organizations such as <a href="https://www.mmv.org/" target=_blank>Medicines for Malaria Venture</a> and the <a href="https://dndi.org/" target=_blank>Drugs for Neglected Diseases Initiative</a>.

Zoliflodacin is not the only success of this model for antibiotic research and development. GARDP is on track to bring about five new treatments over the next five years in a similar way, against other antibiotic-resistant <a href="https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed" target=_blank>bacteria deemed priorities</a> by the World Health Organization. These drugs would otherwise have far less chance of becoming available and affordable to those in need.

More new partnerships producing more new treatments of the sort I could only dream of as a young doctor? This will be pretty remarkable, too.

Manica Balasegaram 

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Getting a gonorrhea antibiotic to regulators is remarkable

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