SIGA Technologies - PALM 007 data warrant a closer look in mpox
Although the topline results of PALM 007 (studying SIGA’s tecovirimat in the treatment of mpox) did not meet the statistical significance for the full population (primary endpoint), we are encouraged by the clinically meaningful benefit reported over placebo in early-treated patients and in those with severe disease. The data highlight an opportunity to establish an effective regime for these key populations, given the lack of effective treatment options and the overall importance of early treatment in infectious diseases. PALM 007 was not a registrational study, and SIGA’s priorities in mpox are the four remaining ongoing studies targeting this indication, which may potentially support a mpox label in the US. Currently, tecovirimat is approved for mpox treatment in the EU and UK.SIGA Technologies is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks, vaccines and therapies for emerging infectious diseases, and health preparedness. The company's primary product is an oral formulation of TPOXX?, an antiviral drug for the treatment of human smallpox disease caused by variola virus. The United States Food and Drug Administration has approved oral TPOXX? for the treatment of smallpox.
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