EPOXI trial Receives Authorization to Begin Enrolling Patients

We are pleased to announce that the European competent authorities have authorized the initiation of the EPOXI trial, which will be testing tecovirimat, as a treatment for human mpox. Regulatory approval was received on the 3rd of June 2024, and we plan to enroll the first participant during the summer of 2024.

The EPOXI trial is a randomized, placebo-controlled, double-blinded study conducted across Europe, adhering to the WHO Master protocol on human mpox (read here). This trial is part of several global studies on tecovirimat based on the WHO Master protocol. It aims at receiving marketing authorization from the European Medicines Agency (EMA) to treat patients with tecovirimat in Europe.

The trial is sponsored by UMC Utrecht and managed by Ecraid, with pharmacovigilance handled by ANRS MIE. Several partners are participating as recruiting sites, including OUH, APHP, SERMAS, UA, and EMC.