SIGA Technologies: Topline results from PALM 007 study of SIGA’s tecovirimat in treatment of mpox released (11.97)
- The National Institutes of Health's National Institute of Allergy and Infectious Diseases announces topline results from a preliminary analysis of the PALM 007 clinical trial. NIAID reported that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the Democratic Republic of the Congo with monkeypox, who were administered SIGA's tecovirimat, a highly targeted antiviral treatment, versus placebo. All patients in this study were hospitalized for the entire duration of treatment. This study was not a registration study conducted under an U.S. FDA Investigational New Drug Application.
- Preliminary analysis shows the study did not reach statistical significance on its primary endpoint of tecovirimat being superior to placebo in lesion resolution for all patients.
- Results suggest tecovirimat provides clinical benefit vs. placebo in two important patient populations: those treated early and those with severe disease.
- Results affirm tecovirimat's strong safety profile.
- Multiple additional clinical trials evaluating tecovirimat for mpox continue.