U.S. starts enrollment in trial testing Siga's antiviral for monkeypox

SIGA Technologies

09/09/2022 17:59

Sept 9 (Reuters) - The National Institutes of Health (NIH)
said on Friday it had started enrolling monkeypox patients in a
late-stage study testing Siga Technologies Inc's  SIGA.O 
antiviral pill Tpoxx against the disease.
    The oral and intravenous formulations of Tpoxx are approved
by the U.S. Food and Drug Administration for the treatment of
smallpox, but does not yet have clearance to treat monkeypox.
    It is, however, currently accessible by clinicians for
treating monkeypox under a compassionate use request.
    The NIH aims to enroll more than 500 patients, including
both adults and children, who will then be randomized to receive
either Tpoxx or placebo pills for 14 days.
    Investigators will evalutate if participants receiving Tpoxx
heal more quickly compared to placebo, as well as provide
critical data on the optimal dosing and safety of the drug in
children and people who are pregnant.
    The United States has recorded more than 21,000 confirmed
cases of monkeypox, according to data from the Centers for
Disease Control and Prevention.

 (Reporting by Raghav Mahobe; Editing by Maju Samuel)
 ((Raghav.Mahobe@thomsonreuters.com;))