EPOXI trial begins enrolling patients with mpox

The EPOXI trial has successfully activated its first sites in Germany and Belgium, with the first patient enrolled on 9 August 2024 at the Institute of Tropical Medicine in Antwerp, Belgium. This marks a significant milestone in ongoing efforts to combat mpox, a disease that the World Health Organisation just declared a global public health emergency for the second time in two years.

Mpox

Mpox is an infectious disease caused by the monkeypox virus. It can cause a painful rash, enlarged lymph nodes and fever. Most people fully recover, but some get very sick. Mpox can be transmitted to humans through physical contact with other patients, contaminated materials, or infected animals. Although mpox infections have significantly decreased in Europe since the peak in 2022, the virus is still active, which raises concerns about potential new outbreaks. Meanwhile, in Africa, mpox is endemic and expanding. Cases have increased by 160% in 2024 compared to 2023, and the virus has caused outbreaks in countries where it was never seen before. This underscores the importance of conducting trials on the efficacy of tecovirimat in mpox patients and monitoring its continued safety.

EPOXI

The randomised, double-blinded EPOXI trial will assess the efficacy and safety of the antiviral drug tecovirimat to treat mpox patients. Tecovirimat has been authorized in the European Union for the treatment of mpox under exceptional circumstances, which is granted to medicines where comprehensive data on the efficacy and safety under normal conditions of use is limited because the condition is rare or because collection of full information is not possible. The EPOXI trial is a collaborative effort of the sponsor University Medical Center Utrecht, Ecraid, Erasmus Medical Centre, University of Antwerp and Servicio Madrileno de Salud (SERMAS). SIGA Technologies have generously donated tecovirimat (TPOXX in US) and matching placebo for this research.  

The EPOXI trial aims to enrol a total of 150 subjects in 12 and 20 sites across 8 to 10 European countries, including the Netherlands, Belgium, France, Germany, Spain, Portugal, Norway, and Italy. The data collected will be combined with data from other global mpox trials, to more rapidly advance the understanding of the drug’s impact.

The EPOXI trial is part of the MPX-Response project, which has received funding from the European Union’s Horizon Europe Research and Innovation programme under grant agreement No. 101115188.