Press release
Topline Results from PALM 007 Study of SIGA’s Tecovirimat in Treatment of Mpox Released
Preliminary analysis shows the study did not reach statistical significance on its primary endpoint of tecovirimat being superior to placebo in lesion
About this update from Siga Technologies Inc.
[{"type":"text","content":"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 patientsResults suggest tecovirimat provides clinical benefit vs. placebo in two important patient populations: those treated early and those with severe diseaseResults affirm tecovirimat’s strong safety profileMultiple additional clinical trials evaluating tecovirimat for mpox continue NEW YORK, Aug. 15, 2024 (GLOBE NEWSWIRE) -- The National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) today announced topline results from a preliminary analysis of the PALM 007 (Tecovirimat for Treatment of Monkeypox Virus) clinical trial (NCT05559099). 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 (DRC) with monkeypox (mpox), 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. A meaningful improvement was observed in patients receiving tecovirimat whose symptoms began seven days or fewer before randomization and in those with severe or greater disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions. While more analysis is required, the Company believes these data support further trials to assess the potential benefit of tecovirimat in those who present to medical care soon after symptoms and in those with severe disease. “These data showing maximum benefit in patients treated early and with severe disease are entirely consistent with the mechanism of action of tecovirimat and with the studies in animals that led to U.S. FDA approval of this medicine for smallpox, a virus closely related to monkeypox virus, but which produces much more severe illness. We believe these data warrant further investigation and support our view that post exposure prophylaxis will be vital for treatment of severe cases of mpox and all cases of smallpox,” stated Dennis Hruby, Chief Scientific Officer. Additionally, in t...