Africa CDC launches pioneering Mpox therapeutic trial as enrollment begins for MOSA Study
Addis Ababa, January 16, 2025 (FMC) – The Africa Centres for Disease Control and Prevention (Africa CDC) has commenced patient enrollment for the MOSA study, a groundbreaking pan-African randomized adaptive trial aimed at finding effective treatments for Mpox. The first participants have been enrolled at Mbandaka Hospital in the Equateur Province of the Democratic Republic of Congo (DRC), a significant milestone in the fight against this health threat.
The trial is particularly timely given the emergence of Clade Ib cases outside Africa and ongoing reports of Clade I and II infections within the continent. Africa CDC, along with the National Institute for Biomedical Research (INRB) and PANTHER, is leading a collaborative effort to evaluate promising therapeutic options as Mpox continues to pose a considerable risk, especially to vulnerable groups such as women, children, and individuals living with HIV.
Designated a Public Health Emergency of Continental Security on August 13, 2024, Mpox remains largely untreated, with no approved therapies available in either the United States or Africa. Previous studies, such as PALM 007 and STOMP, indicated that tecovirimat was not effective in resolving lesions, highlighting the urgent need for new treatment options.
The MOSA trial exemplifies Africa’s proactive leadership in addressing healthcare challenges. It will assess various antiviral treatments, starting with brincidofovir, developed by Emergent BioSolutions. Although available in the U.S. under an emergency use Investigational New Drug (IND) for Mpox, brincidofovir’s safety and efficacy for this purpose have yet to be established in controlled trials. Participants in the trial will receive either brincidofovir or a placebo through a liquid oral formulation over two weeks.
An initial analysis of the trial’s data is expected by the end of the first quarter of 2025.
“Africa is not just reacting to the Mpox crisis; we are at the forefront of finding solutions through rigorous research and development,” stated Dr. Jean Kaseya, Director General of Africa CDC. “The MpOx Study is a pivotal step toward creating effective treatments, reflecting our commitment to tackling the continent’s health challenges with innovative research.”
The MOSA trial is supported by PANTHER, with initial funding from the European Union’s Horizon Europe program. Marc Lemaître, Director-General for Research and Innovation at the European Commission, praised the trial’s operational launch, noting its significance in addressing the Mpox outbreak.
The trial protocol has received ethical and scientific approval through the AVAREF collaborative process in 2023, ensuring its adherence to the highest standards. The innovative design includes pre-planned interim analyses to facilitate quick decision-making based on initial results.
Prof. Samba Ousmane Sow, Director General of the Centre for Vaccine Development in Mali (CVD-Mali) and President of PANTHER’s Board, expressed his pride in this development, stating, “This milestone underscores PANTHER’s mission to tackle epidemic priorities across the continent, aiming to improve our responses to current and future health crises.”
With Mpox cases increasing, particularly in the DRC, the MOSA trial aims to generate crucial data on treatment potentials, particularly for high-risk populations in remote regions.
Prof. Placide Mbala, Principal Investigator for the study in the DRC, noted, “MOSA represents another vital research initiative that complements our ongoing work on transmission, vaccines, and the social sciences related to Mpox.”
Dr. Simon Lowry, chief medical officer and head of research and development at Emergent, emphasized the global significance of Mpox, stating, “We commend Africa CDC and PANTHER for advancing the MOSA study, which is vital for developing treatments and vaccines against this public health threat.”