Smallpox drug, TEMBEXA®, set for clinical trials to treat Mpox in Africa
African health authorities and Maryland-based global life sciences company, Emergent BioSolutions, recently announced that US approved smallpox drug, brincidofovir (brand name TEMBEXA®) will be included in a clinical trial conducted and sponsored by PANTHER, under the leadership of the Africa Centres for Disease Control and Prevention (Africa CDC), as part of the ‘MpOx Study in Africa’ (MOSA). The study will evaluate the safety and efficacy of brincidofovir in treating mpox virus in a randomized double-blind placebo-controlled trial.
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.
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.
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.
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“We applaud Africa CDC and PANTHER for the launch of the ‘MpOx Study in Africa’ (MOSA), an important step in advancing research for brincidofovir, and are proud to support the trial with our brincidofovir antiviral treatment,” said Joe Papa, President and CEO of Emergent BioSolutions. “Emergent is committed to working with global partners to study and produce vaccines and treatments addressing all orthopoxviruses, including mpox and smallpox.”
On August 13, Africa CDC declared mpox a public health emergency of continental security, which was followed by a statement from World Health Organization’s Director-General declaring that the upsurge of mpox in the DRC and a growing number of countries in Africa constitutes a public health emergency of international concern under the International Health Regulations (2005).
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.
To date in 2024, between epidemiological weeks 1 and 43, a total of 49,310 cases of mpox, of which, 10,672 have been confirmed, and 1,059 deaths [case fatality rate (CFR): 2.15%] have been reported from 19 African Union (AU) Member States (MS).
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