NIH Launches Phase 3 Trial Of Monkeypox Med TPOXX

From the National Institutes of Health:

A Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, is now enrolling adults and children with monkeypox infection in the United States.

Study investigators aim to enroll more than 500 people from clinical research sites nationwide. Interested volunteers can visit the ACTG website for more information.

The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The NIAID-funded AIDS Clinical Trials Group is leading the study, which may later expand to international sites.

Tecovirimat, manufactured by the pharmaceutical company SIGA Technologies, Inc., New York City, is approved by the U.S. Food and Drug Administration for the treatment of smallpox.

The drug prevents the virus from spreading in the body by preventing virus particles from exiting human cells by targeting a protein found on both the variola virus, which causes smallpox, and the monkeypox virus.

Clinicians currently can access tecovirimat for U.S. patients with monkeypox through an expanded access or “compassionate use” request process.

“Monkeypox can be an extremely painful infection that lasts for weeks,” said NIAID Director Anthony S. Fauci, M.D.

“We currently lack efficacy data that would help us understand how well this drug may mitigate painful monkeypox symptoms and prevent serious outcomes. This clinical trial was designed to answer those important questions.”