NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution or Pain
December 10, 2024
The STOMP trial, led by the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID), found tecovirimat ineffective against mild to moderate clade II mpox. Despite its FDA approval for smallpox, the antiviral did not reduce lesion resolution time or alleviate pain. The trial’s Data Safety and Monitoring Board recommended halting enrollment after determining further testing would be futile. This outcome underscores the need for rigorous, well-designed clinical trials during health crises. Moving forward, NIAID and its partners must prioritize developing novel mpox treatments while strengthening global pandemic preparedness through collaborative research and medical innovation.
The National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID) have concluded the international STOMP trial evaluating tecovirimat as a treatment for clade II mpox. Despite high hopes, the antiviral failed to reduce lesion resolution time or alleviate pain in mild to moderate cases. Following a recommendation from the trial’s Data Safety and Monitoring Board, enrollment was halted due to the drug’s lack of efficacy.
Conducted across several countries, including the U.S., Argentina, and Thailand, STOMP was a large-scale, randomized, placebo-controlled trial. Patients with severe mpox or high-risk factors received tecovirimat in an open-label study arm. However, even among those groups, no meaningful improvement in symptoms was observed.
NIAID Director Dr. Jeanne Marrazzo emphasized that STOMP’s findings reinforce the need for rigorous clinical trials during outbreaks, especially when repurposing antivirals. Tecovirimat’s failure as a viable mpox treatment highlights the complexities of adapting existing therapies to new health threats.
Looking ahead, NIAID and its global partners remain committed to advancing mpox treatment research. Efforts include developing novel therapeutics through initiatives like the Antiviral Program for Pandemics and the Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness Network. STOMP’s legacy lies in its scientific rigor and global collaboration—essential pillars of future pandemic preparedness.