Hunt for infectious disease treatments takes on new urgency

Researchers at Johns Hopkins and elsewhere have launched a major study on a drug to treat mpox

Published on: January 18, 2023 6:00 AM EST|Updated on: January 18, 2023 10:44 AM EST

A vial of smallpox/monkeypox vaccine is seen during a vaccination event at the Pride Center on July 12, 2022 in Wilton Manors, Florida. The center is offering the free smallpox/monkeypox vaccinations from the Florida Department of Health in Broward County as South Florida leads the state in the number of people infected.
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When monkeypox cases began spiking in early June, some of those infected and at risk were dismayed that there weren’t proven therapies ready.

There was a promising treatment, tested in animals but not humans, for the infections regularly seen in Africa but rarely reported in Europe or North America.

The drug was used sparingly before the emergency began abating. But instead of putting the tecovirimat, or TPOXX, back on the shelf, researchers at Johns Hopkins and elsewhere launched a major study to confirm it worked for monekypox, now known as mpox.

“There has been a drop in cases which is great for the community,” said Dr. Matthew Hamill, an assistant professor of medicine at Johns Hopkins University and the study’s local principal investigator.

“It does make recruitment more challenging,” he said. “However, unless we conduct this trial we will never be sure if TPOXX actually works to treat mpox infections.”

Hamill said the urgency reflects a change in public expectations that accelerated during the coronavirus pandemic: that treatments and vaccines should be developed in close to real time. At least, they should not take years or decades.

COVID-19 vaccines were developed, tested and given emergency authorization in less than a year. Federal officials said the unprecedented effort to make doses available cut no safety corners, though it required an investment of billions of dollars.

In Baltimore, which had an mpox outbreak largely among Black men in the gay community, officials faced criticism for the slow rollout of vaccines and TPOXX, both from the National Strategic Stockpile. They were given only to the most affected and at-risk people until supplies caught up with demand.

More than 1.16 million people have gotten the mpox vaccine nationally, according to the U.S. Centers for Disease Control and Prevention. But with close to 30,000 cases reported, only 6,743 people have been given TPOXX, which is approved only for treatment of smallpox but allowed for mpox during the outbreak.

Dr. Letitia Dzirasa, Baltimore health commissioner, said there “certainly were a lot of expectations when this additional public health emergency came up” in the middle of the coronavirus pandemic. She said the city was hampered because it had resources dedicated to COVID but not other emergencies.

“People were like, ‘Why can’t I get this vaccine, I should be allowed to get this,’” she said. “There were a lot of expectations that we tried to temper.”

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Dzirasa noted federal officials have begun reconsidering how much time clinical trials should take. The U.S. Food and Drug Administration estimates approvals now take about 12 years.

“There are going to be additional acute emerging infections. I do believe there is a focus on how we are able to bring treatments to market sooner,” she said. “I support that.”

Hamill said he’s pleased the TPOXX studies got underway so quickly with federal funding.

Mpox can cause weeks of painful lesions, aches and swollen lymph nodes. TPOXX was ready for testing but had been skipped over due to scarce resources and the sense that mpox “was a tropical infection and something we didn’t need to worry about here.”

He also said mpox was largely affecting Black men in the often marginalized LGBTQ community.

Hamill, an HIV researcher, took up the monkeypox trial because it had a similar path to HIV, spreading among sexual partners (though it’s not normally considered a sexually transmitted disease). He wanted to make sure the population hit hard by both diseases was included in the research.

That means reaching infected young Black men showing symptoms for two weeks or less. He hopes for at least 10 or 15 volunteers, rather than hundreds due to the dearth of current infections.

While cases abated faster than expected, likely due to the vaccine and changes in behavior, Hamill touted the quick trial launch.

He compared it to trials for HIV treatments, which spread rapidly in the 1980s. While one drug, AZT, was available in a few years, it didn’t work well and had significant side effects. It wasn’t until the late 1990s when better treatments were available. Now infections are managed with a daily pill.

There is also a pill to prevent HIV infections, noted Dr. Robert Gallo, director at the Institute of Human Virology at the University of Maryland School of Medicine and one of the scientists credited with discovering HIV.

Supporting that kind of success, and disseminating effective treatments, is why he said he co-founded the Global Virus Network, which supports medical research and the response to threats.

Gallo said he hopes the public demands better and faster treatments, including more for COVID-19.

There have been breakthroughs in vaccines and treatments, he said. But the coronavirus continues to mutate and pose challenges for them. The vaccines don’t prevent infections well, though they prevent severe cases. Monoclonal antibody treatments, he said, are working on all of the coronavirus variants.

Mpox, though less a threat, is likely to return, he said.

“As a virologist I understand there are all kinds of priorities on Earth, but when something isn’t a hot problem, causing lots of deaths, people’s minds go elsewhere,” he said. “We need to keep it on the burner.”