Emergent BioSolutions Backs New Clinical Trial for Brincidofovir Against Mpox Virus in Africa

Emergent BioSolutions Inc. has announced that its antiviral medication, brincidofovir, known commercially as TEMBEXA®, will be a part of a clinical trial backed by PANTHER. This initiative, under the guidance of the Africa Centres for Disease Control and Prevention (Africa CDC), is part of a wider study called the 'MpOx Study in Africa' (MOSA). The trial aims to evaluate the safety and effectiveness of brincidofovir in treating the mpox virus through a randomized, double-blind, placebo-controlled study.

Joe Papa, the president and CEO of Emergent BioSolutions, praised the Africa CDC and PANTHER for their efforts in initiating the MOSA study. He emphasized Emergent's dedication to collaborating with global partners in researching and developing vaccines and treatments for orthopoxviruses, including mpox and smallpox.

Brincidofovir is an antiviral treatment included in Emergent’s range of products. Currently, there are no FDA-approved treatments specifically for patients with mpox who are at risk of severe health complications. While brincidofovir can be used under emergency Investigational New Drug protocol for mpox in the U.S., it has not been subjected to any randomized, double-blind, placebo-controlled trials for this particular virus.

On August 13, Africa CDC declared mpox a public health emergency, which was later echoed by the World Health Organization's Director-General. The announcement highlighted the increasing mpox cases in the Democratic Republic of Congo and other African nations, classifying it as a public health emergency of international concern under the International Health Regulations (2005).

The MOSA study is a comprehensive, double-blind, platform adaptive trial designed to assess treatments for patients diagnosed with the mpox virus. The trial will include children and adults with mucosal lesions or those living with HIV. PANTHER sponsors this trial as part of the MPX-RESPONSE Project, which is funded by the European Union’s Horizon Europe Research and Innovation program, under grant agreement 101115188. The study will start in the coming weeks in the Democratic Republic of Congo and neighboring regions.

Emergent BioSolutions has a mission to protect and enhance life, dedicating over 25 years to safeguarding people from unpredictable threats through its portfolio of vaccines and therapeutics. The company also offers integrated contract development and manufacturing services for pharmaceutical and biotechnology clients.