A drug currently approved for smallpox in the U.S. will undergo clinical trials to treat patients infected by the Mpox virus who are at risk of severe complications in the Democratic Republic of Congo and neighboring countries, starting in the fourth quarter of this year.
The development was announced on the Africa Center for Disease Control and Prevention (Africa CDC) website on Friday.
They explained that the MpOx Study in Africa (MOSA) will evaluate the safety and efficacy of brincidofovir, an antiviral developed by global life sciences company Emergent BioSolutions.
“Brincidofovir has not yet been tested in double-blind, placebo-controlled studies for Mpox. This trial represents a significant advance in research on the viral disease, which spreads through close contact with an infected person or animal across Africa”, the announcement read.
Emergent BioSolutions announced on November 6 that the clinical trial will be conducted and sponsored by PANTHER (the PANdemic preparedness plaTform for Health and Emerging infectious Response), under the leadership of the Africa CDC.
Declared a Public Health Emergency of Continental Security on August 13, 2024, Mpox remains a significant health threat across Africa, particularly for vulnerable populations such as women, children, patients with mucosal lesions, and individuals living with HIV. Despite the urgent need, there is currently no approved therapeutic to treat Mpox and alleviate the suffering of those already infected and at risk of severe complications.
MOSA, a pan-African, randomized, platform-adaptive trial, demonstrates Africa’s leadership in addressing this urgent healthcare gap. The trial is funded initially by the European Union’s Horizon Europe program.
A virologist and head of the National Biomedical Research Institute in Kinshasa, Professor Placide Mbala will lead the study. Patients from Equateur Province, particularly Bikoro and Mbandaka, will be enrolled, according to a spokesperson for the study. Nigeria, Central African Republic, Republic of Congo, and Cameroon are also considered as potential sites for the trial.
“Equateur has consistently reported a high number of cases. Recently, a high number of patients were also identified in Kinshasa. Other countries, such as Burundi, are also reporting significant case numbers alongside several African nations,” the spokesperson added.
The study researchers noted that brincidofovir is approved for use in adult and pediatric patients, including infants. “This is important as we may enroll children with measles co-infection who could have just been vaccinated against measles. However, we do not plan to enroll patients who have recently received a vaccination against Mpox,” the researchers stated.
Speaking about the development, Director General of Africa CDC, Dr. Jean Kaseya stated, “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”.
