Mpox Crisis in Africa Intensifies as Tpoxx Trials Offer Mixed Results

Preliminary results from a study conducted in the Democratic Republic of the Congo (DRC) during the 2022 mpox outbreak have provided mixed outcomes for SIGA Technologies' smallpox antiviral, Tpoxx. The trial, known as PALM 007, did not achieve its primary goal of reducing the time to lesion resolution within a 28-day treatment period. However, significant improvement was noted in patients who began treatment within seven days of symptom onset and in those with severe cases, defined by the presence of 100 or more skin lesions. These findings support the potential of Tpoxx as a post-exposure treatment for smallpox and severe mpox, although the overall results were influenced by the controlled hospital environment where patients received high levels of care.

Despite missing the primary endpoint, SIGA Technologies remains optimistic about Tpoxx's potential. The company highlighted that the trial's setting may have impacted the placebo group's favorable outcomes, reducing the measured benefit of Tpoxx. As a result, SIGA and the National Institute of Allergy and Infectious Diseases (NIAID), which sponsored the trial, are conducting further analysis to better understand the data. Additional randomized trials are currently underway in various countries, including the U.S., Europe, Canada, and South America, each with different study designs and patient populations.

The study results come as a new strain of mpox spreads across Africa, prompting the World Health Organization (WHO) to declare it a global health emergency. Since January 1, over 17,000 cases and 500 deaths have been reported across 13 African countries. The U.S. has responded by purchasing an additional $113 million worth of Tpoxx, reinforcing its role in combating both smallpox and mpox. However, caution remains, as the rapidly evolving nature of the virus could impact Tpoxx's long-term effectiveness.

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