- On Friday, the National Institutes of Health (NIH) announced the start of a late-stage clinical trial to test Siga Technologies’ ( NASDAQ: SIGA ) Tpoxx antiviral pill on monkeypox patients.
- Tpoxx, approved in the U.S. for related smallpox infection, is also used to treat monkeypox on a case-by-case basis under the FDA's Expanded Access program.
- The NIH-led trial is expected to enroll 500 patients, both adults and children, who will be randomized to receive Tpoxx, also known as Tecovirimat, and the placebo.
- The study is designed to measure if Tpoxx recipients heal faster than those who receive the placebo and obtain critical data on optimal dosing and safety for children and pregnant women.
- Recently, a team of British scientists, who conducted one of the major clinical trials to find COVID-19 therapies, started a similar trial for Tpoxx in the U.K.
For further details see:
Siga monkeypox therapy undergoes NIH-led late-stage trial