'NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution Or Pain'

Author: Benzinga Newsdesk | December 10, 2024 02:38pm

https://www.niaid.nih.gov/news-events/nih-study-finds-tecovirimat-was-safe-did-not-improve-mpox-resolution-or-pain

Study Examined Tecovirimat in Countries Affected by Global Clade II Mpox Outbreak

 

The antiviral drug tecovirimat did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease, according to an interim data analysis from the international clinical trial called the Study of Tecovirimat for Mpox (STOMP). There were no safety concerns associated with tecovirimat. 

Considering these definitive findings, the study's Data Safety and Monitoring Board (DSMB) recommended stopping further enrollment of participants who were being randomized to tecovirimat or placebo. As the study sponsor, the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) accepted the DSMB's recommendation. Given the lack of an efficacy signal, NIAID also closed enrollment into an open-label study arm for participants with or at elevated risk of severe disease that was not designed to estimate the drug's efficacy. 

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