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), as part of the ‘MpOx Study in Africa’ (MOSA). This randomized, double-blind, placebo-controlled trial will assess the safety and efficacy of brincidofovir in treating mpox virus. The study is scheduled to begin in the Democratic Republic of Congo and neighboring countries.
Joe Papa, president and CEO of Emergent BioSolutions, stated, “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.”
Clinical Trial Details
The MOSA trial is a pan-African, double-blind, platform adaptive trial assessing treatments for patients diagnosed with mpox virus. Inclusion criteria are children, adults with mucosal lesions, or people living with HIV (PLWHIV). The trial is sponsored by PANTHER as part of the MPX-RESPONSE Project, funded by the European Union’s Horizon Europe Research and Innovation program.
Brincidofovir as a Medical Countermeasure
Brincidofovir is an antiviral medical countermeasure in Emergent’s product portfolio. Currently, there are no FDA-approved therapeutics for mpox virus-infected patients at risk of severe complications. While brincidofovir is available for mpox treatment in the U.S. under an emergency Investigational New Drug (IND) protocol, it has not been evaluated in randomized, double-blind, placebo-controlled studies for mpox.
Public Health Emergency
On August 13, the Africa CDC declared mpox 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).
