Brincidofovir Evaluated in Mpox Clinical Trial Across Africa
Key Insights
Emergent BioSolutions supports a clinical trial led by Africa CDC (search) to assess brincidofovir's safety and efficacy in treating mpox (search) virus.
The MOSA study is a pan-African, double-blind, placebo-controlled trial focusing on children, adults with mucosal lesions, and PLWHIV.
Brincidofovir, currently available under emergency IND protocol in the U.S., lacks evaluation in randomized, placebo-controlled mpox (search) studies.
Emergent BioSolutions Inc. (NYSE: EBS) announced that brincidofovir (TEMBEXA®) will be evaluated in a clinical trial conducted by PANTHER, under the leadership of the Africa Centres for Disease Control and Prevention (Africa CDC (search)), as part of the ‘MpOx (search) Study in Africa’ (MOSA). This randomized, double-blind, placebo-controlled trial will assess the safety and efficacy of brincidofovir in treating mpox virus.
MOSA Trial Details
The MpOx (search) Study in Africa (MOSA) is a pan-African, double-blind, platform adaptive trial designed to evaluate treatments for patients diagnosed with mpox virus. The study's inclusion criteria encompass children, adults presenting with mucosal lesions, and people living with HIV (search) (PLWHIV). Sponsored by PANTHER as part of the MPX-RESPONSE Project, which is funded by the European Union’s Horizon Europe Research and Innovation programme, the trial is set to begin in the Democratic Republic of Congo and neighboring countries in the coming weeks.
Brincidofovir and Mpox Treatment
Brincidofovir is an antiviral medical countermeasure within Emergent BioSolutions’ product portfolio. Currently, there are no FDA-approved therapeutics specifically for treating mpox (search) virus infections in patients at risk of severe complications. While brincidofovir is accessible for mpox treatment in the U.S. under an emergency Investigational New Drug (IND) protocol, its efficacy has not yet been evaluated in randomized, double-blind, placebo-controlled studies for mpox.
Public Health Context
On August 13, the Africa CDC (search) declared mpox (search) a public health emergency of continental security. Subsequently, the World Health Organization’s Director-General announced 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).
Executive Commentary
“We applaud Africa CDC (search) and PANTHER for the launch of the ‘MpOx (search) 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, Emergent BioSolutions. “Emergent is committed to working with partners around the world to study and produce vaccines and treatments to address all orthopoxviruses, including mpox and smallpox.”