First pill for dengue shows result at human challenge trial, promises hope

Dengue virus infects up to 400 million people every year worldwide. Typically found in tropical and sub-tropical climates dengue continues to remain a potential threat as no medicines have been found for it. Recently, a pill for dengue fever developed by Johnson & Johnson appeared to protect against a form of the virus in a handful of patients in a small human challenge trial in the United States, according to data presented by the company on Friday. There are currently no specific treatments for dengue, a growing disease threat, the company said ahead of the presentation of the data at the American Society of Tropical Medicine and Hygiene Annual Meeting in Chicago.

"The data showed that the compound induced antiviral activity against dengue (DENV-3) in humans, compared to placebo, and is safe and well-tolerated. The data were announced at the American Society of Tropical Medicine & Hygiene Annual Meeting in Chicago, Illinois," J&J has said in an official statement. In the trial done with Johns Hopkins Bloomberg School of Public Health, 10 volunteers were given a high dose of the J&J pill five days before being injected with a type of dengue. They continued to take the pill for 21 days afterwards. The study is being conducted in 30+ sites in 10 countries, including Philippines, Thailand, Peru, Brazil and Colombia.

In the first phase trial, the compound is found to have antiviral activity against DENV 3. Six of the 10 showed no detectable dengue virus in their blood after being exposed to the pathogen, as well as no signs that their immune system had responded to infection by the virus over 85 days of monitoring. The five people in a placebo group, who were also injected with dengue, all showed detectable virus when tested. Trial participants received standard care from medical professionals where necessary, and the virus used was a weakened version to minimize symptoms. The positive early data supports ongoing Phase II trials of the pill to prevent the four different types of dengue in a real setting where the disease is common, J&J said. The next step will be testing it as a treatment.

The drug works by blocking the action of two viral proteins, preventing the virus from making copies of itself. It was well-tolerated by all trial participants, J&J said. A key question for the future will be ensuring access to the new drug, if it works on a larger scale, in many of the low- and middle-income countries where it is most needed, an echo of the challenge for the dengue vaccine the WHO backed earlier this month. “We’re working on it,” said Van Loock, adding that it was early days.

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Dengue fever, while often asymptomatic, is also known as “break-bone fever” for the severity of the joint pain and spasms that some patients experience. It has long been a scourge across much of Asia and Latin America, causing millions of infections each year and tens of thousands of deaths, and is likely to spread further as climate change makes more areas hospitable for the mosquitoes that spread it, the World Health Organization’s chief scientist Jeremy Farrar said earlier this month.

The common symptoms of dengue fever are high fever (104F), severe headache, pain behind the eyes, muscle and joint pains, nausea, vomiting, swollen glands, and rash. Health experts say that it is riskier when dengue affects an individual for the second time. In severe cases, the individual experiences severe abdominal pain, persistent vomiting, rapid breathing, bleeding gums, fatigue, restlessness, extreme thirst, and fatigue.

(With inputs from Reuters)