The National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) announced preliminary results from the PALM 007 trial evaluating tecovirimat, an antiviral medication marketed as Tpoxx by SIGA Technologies, for the treatment of monkeypox (mpox). The trial, conducted in the Democratic Republic of Congo, aimed to determine if tecovirimat could significantly reduce the time it took for lesions to heal in patients with mpox. However, the study did not meet its primary endpoint.
While tecovirimat did not demonstrate an overall statistically significant improvement in lesion resolution, a meaningful benefit was observed in patients with severe disease or those whose symptoms began within seven days of starting the medication. This suggests potential utility for tecovirimat in specific patient populations.
The study also highlighted the importance of supportive care in managing mpox. The overall mortality rate in the PALM 007 trial, regardless of treatment group, was significantly lower than the reported mortality rate for mpox cases in the DRC. This suggests that hospitalization and high-quality care can significantly improve outcomes for patients with mpox.
Despite the mixed results, NIAID believes that further research into tecovirimat is warranted, particularly for post-exposure prophylaxis and the treatment of severe mpox cases. The company also reported that tecovirimat exhibited a safe profile comparable to placebo, reinforcing its established safety record over the past 15 years.
The PALM 007 trial was part of a global effort to address the 2022 mpox outbreak. The trial’s design and findings will be closely analyzed to understand the nuances of tecovirimat’s effectiveness and the role of supportive care in managing mpox.
Following the announcement, SIGA Technologies’ stock price dropped significantly, reflecting the market’s reaction to the trial’s results. This news emphasizes the need for ongoing research and development of effective treatments for mpox.
