The first patients have been enrolled in the MOSA trial, a pivotal clinical trial evaluating treatments for Mpox (formerly known as monkeypox) at Mbandaka Hospital in the Democratic Republic of Congo (DRC). Supported by Africa CDC and initially funded by the European Union, this pan-African trial is a crucial step in addressing the ongoing Mpox health threat, especially as new clades emerge and cases persist across Africa. The trial aims to fill the significant therapeutic gap, as no approved Mpox treatment currently exists in the US or Africa.
This trial is particularly important because it demonstrates proactive leadership from African institutions in addressing a critical health concern impacting the continent. The lack of approved therapeutics underscores the urgent need for research and development, particularly given the vulnerability of specific populations like women, children, and individuals with HIV. The emergence of new Mpox clades further emphasizes the need for effective treatments.
The MOSA trial is designed as a randomized, adaptive platform study, initially evaluating the safety and efficacy of brincidofovir, an antiviral drug developed by Emergent BioSolutions. This drug is currently available in the US under a single-patient emergency use Investigational New Drug (IND) application, but its efficacy against Mpox remains unproven in rigorous clinical trials. The trial’s adaptive design allows for the evaluation of other antiviral candidates, alone or in combination, and incorporates interim analyses for efficient decision-making based on emerging data. The first interim analysis is anticipated by the end of the first quarter of 2025.
The initiation of the MOSA trial marks a significant advancement in the fight against Mpox. It highlights the importance of international collaboration and research preparedness in responding to emerging infectious diseases. The trial’s results are eagerly anticipated and could potentially lead to the first approved Mpox treatment, significantly improving outcomes for patients in Africa and globally. The study’s focus on including children and adults, especially those in remote and high-risk areas, reinforces its commitment to equitable healthcare access and addressing the needs of vulnerable populations.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
