SIGA’s drug, branded TPOXX, has been cleared to treat diseases caused by the family of orthopoxvirus that includes smallpox, monkeypox and cowpox by the European Union and UK, but due to limited trial data it is generally only used in severe cases in Britain.
In the US and Canada, the drug is only approved to treat smallpox.
Since smallpox has been eradicated, and cases of monkeypox and cowpox typically occur sporadically, studies to assess the effectiveness of the drug in infected people have so far not been carried out.
Instead, its effectiveness is based on studies in animals infected with lethal doses of orthopoxviruses, as well tests of the medicine’s effects in healthy humans.
The PLATINUM trial, funded by a £3.7 million (US$4.35 million) UK government grant, aims to recruit at least 500 participants. Participants will either be given a 14-day course of tecovirimat twice daily, or a placebo.
To assess the drug’s effectiveness, the rate at which lesions heal, the time taken until patients test negative for the virus, and the proportion of patients who require hospitalisation due to complications will be tracked.
“I’m hoping that we can have a result before Christmas, but it depends on the rate of recruitment,” said Sir Peter Horby, Professor of Emerging Infections and Global Health at the University of Oxford and the director of the new Pandemic Sciences Institute.
Earlier this month, US officials indicated they were planning a randomised clinical trial in the country to determine whether tecovirimat should secure US approval for monkeypox.
SIGA, which sells an oral and intravenous formulation of the drug, has already received US$60 million worth of orders for oral tecovirimat this year.
Meanwhile, the only approved monkeypox vaccine – made by Danish company Bavarian Nordic – is in short supply, pushing countries to stretch existing supplies.
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