The MOSAIC cohort (WP2) provided comprehensive insights into the clinical and virological characteristics of mpox caused by the clade IIb variant. The study underscored the need for continued research and forms the basis of a clinical characterization protocol for the ongoing mpox outbreaks. Findings were published in the Clinical Infectious Diseases (early 2025), and sub-studies are underway to assess the long-term immune responses.
The EPOXI trial (WP3) was designed to evaluate the efficacy and safety of tecovirimat for mpox, with the goal of securing marketing authorization from the EMA. Despite regulatory approvals in eight EU countries and the initiation of patient recruitment in mid-2024, the trial was halted prematurely in summer 2025 following reports from the UNITY study indicating that the drug did not reduce time to lesion resolution. The results will be included in a pooled Individual Participant Data Meta-Analysis (IPDMA).
UNITY and MOSA (WP4) are two RCTs designed to assess the efficacy and safety of antiviral treatments for mpox in different global regions. UNITY focuses on Brazil, Argentina, and Switzerland, while MOSA is centered in sub-Saharan Africa, where the disease is endemic and a different clade of mpox is circulating. During RP3, UNITY successfully completed recruitment, enrolling 480 participants in its randomized arm. The database was locked in July 2025, and results were presented at the IAS 2025 conference in Kigali. The findings confirmed that tecovirimat did not improve lesion resolution or other clinical outcomes, aligning with results from other trials such as STOMP and PALM007. The open-label arm was closed in July 2025, and preparations for an IPDMA are underway, involving UNITY, STOMP, EPOXI, and PLATINUM trials.
In parallel, MOSA advanced significantly as a platform-adaptive trial, integrating brincidofovir as a new treatment arm following tecovirimat’s reported absence of efficacy. The first patient was enrolled in December 2024, with 33 participants recruited during RP3. The trial expanded its regulatory footprint to Uganda and Sierra Leone. MOSA also secured additional funding from Africa CDC, supplementing EU support.
