Emergent BioSolutions' brincidofovir, a drug approved for smallpox in the U.S., is set to undergo clinical trials in Africa to treat Mpox virus infections. The MpOx Study in Africa (MOSA) will evaluate the antiviral's safety and efficacy in patients at risk of severe complications in the Democratic Republic of Congo and neighboring countries, with the trial commencing in the fourth quarter of this year.
MOSA Trial Details
MOSA is a pan-African, randomized, platform-adaptive trial sponsored by PANTHER (the PANdemic preparedness plaTform for Health and Emerging infectious Response) under the leadership of the Africa CDC. The trial is initially funded by the European Union’s Horizon Europe program. The study protocol underwent review in 2023 through the African Vaccine Regulatory Forum (AVAREF) collaborative process, ensuring adherence to high ethical and scientific standards. The trial design incorporates pre-planned interim analyses to facilitate rapid decision-making based on early signs of futility or success.
Addressing an Urgent Need
Mpox was declared a Public Health Emergency of Continental Security on August 13, 2024, and remains a significant health threat in Africa, particularly for vulnerable populations such as women, children, patients with mucosal lesions, and individuals living with HIV. Currently, there is no approved therapeutic to treat Mpox and alleviate the suffering of those already infected and at risk of severe complications.
Leadership and Implementation
Professor Placide Mbala, a virologist and head of the National Biomedical Research Institute in Kinshasa, will lead the study. Patient enrollment will begin in Equateur Province, particularly Bikoro and Mbandaka. Nigeria, Central African Republic, Republic of Congo, and Cameroon are also being considered as potential trial sites.
Brincidofovir's Potential
Researchers have noted that brincidofovir is approved for use in adult and pediatric patients, including infants. This is particularly relevant as the trial may include children with measles co-infection who may have recently been vaccinated against measles. However, the study will exclude patients recently vaccinated against Mpox.
Quotes from Key Stakeholders
Dr. Jean Kaseya, Director General of Africa CDC, emphasized Africa's leadership in Mpox research and development, stating, "Africa is not just responding to the Mpox outbreak; we are leading the charge by spearheading research and development for Mpox therapeutics. The MpOx Study in Africa is a groundbreaking step toward developing an effective treatment that will save lives. This goes beyond research—it’s about African ownership and leadership in tackling our continent’s health challenges through essential research."
Prof. Samba Ousmane Sow, Director General of the Centre for Vaccine Development in Mali (CVD-Mali) and President of the Board of PANTHER, added, "The launch of MOSA marks a significant stride in the fight against Mpox and underscores Africa’s leadership in global health research and innovation. Our collaboration with Africa CDC will not only address an urgent health crisis but also set a new standard for African-led research initiatives."
