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EPOXI trial receives regulatory approval to start patient enrolment

On 3 June 2024, the European competent authorities authorised the initiation of the EPOXI trial which will be investigating a potential treatment for mpox. The trial team now aims to enrol its first participant this summer.

  

EPOXI is a randomised controlled double-blinded trial that will test the efficacy and safety of the antiviral drug tecovirimat. Tecovirimat has been authorised in the EU under exceptional circumstances for the treatment of mpox, but randomised data in patients are still lacking. The trial aims to provide such data within the EU regulatory framework. It is compliant with Regulation EU 536/2014 and has followed the regulatory review procedures in the Clinical Trials Information System (CTIS). 

Mpox infections have significantly decreased in Europe since the peak in the summer of 2022, but cases are still occurring sporadically, and it is feared that there may be novel outbreaks. Furthermore, at this moment there are still no antivirals available with clinically proven efficacy against mpox. The study sponsor UMC Utrecht (the Netherlands), Ecraid and their international partners have set out to capture the still sporadically occurring mpox cases in Europe and provide efficacy and safety data. The trial will run in Portugal, Italy, Germany, France, Spain, Norway, Belgium and the Netherlands. 

Eligible mpox patients who are interested in participating in the trial can be referred to the participating trial centres in the respective countries. After the patient has provided a written consent to participate in the trial, he or she will be randomly allocated to receive treatment with tecovirimat or matching placebo (in a 2:1 ratio) for 14 days. All participants will be followed up for 90 days and will be asked to complete several self-assessments. They will also be asked to attend five live and two remote (phone) visits. Several samples will be collected during the live visits to test for continuous infection.

The trial targets to enrol 150 participants in Europe. These data will be combined with data collected in other mpox trials in South America and Africa.

EPOXI is part of the MPX-RESPONSE project which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101015736. Read more about the trial here.