Smallpox Drug in Clinical Trials for the Treatment of Mpox in Africa – Africa CDC

A drug currently approved in the United States for smallpox will be tested in clinical trials starting in the fourth quarter of this year to treat patients infected with the Mpox virus in the Democratic Republic of Congo and neighboring countries who are at risk of serious complications .

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 against Mpox in double-blind, placebo-controlled studies. This trial represents a significant advance in research into the viral disease, which spreads across Africa through close contact with an infected person or animal.

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), led by the Africa CDC.

“We applaud Africa CDC and PANTHER for launching the 'MpOx Study in Africa' (MOSA), an important step in advancing brincidofovir research, and are proud to support the study 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 against all orthopoxviruses, including Mpox and smallpox.”

Declared a public health emergency by Continental Security on August 13, 2024, Mpox continues to pose 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 already infected individuals who are at risk of serious complications.

MOSA, a pan-African, randomized, platform-adaptive trial, demonstrates Africa's leadership in closing this urgent health gap. The trial is initially funded by the European Union's Horizon Europe program. The study protocol was reviewed in 2023 as part of the African Vaccine Regulatory Forum (AVAREF) collaborative process to ensure compliance with the highest ethical and scientific standards. The innovative study design includes pre-planned interim analyzes that enable rapid decision-making when the first signs of futility or success are observed.

Professor Placide Mbala, virologist and head of the National Biomedical Research Institute in Kinshasa, will lead the study. According to a spokesman for the study, patients will be enrolled from Equateur province, particularly Bikoro and Mbandaka. Nigeria, the Central African Republic, the Republic of Congo and Cameroon are also considered potential locations for the trial.

“Equateur has consistently reported a high number of cases. Recently, numerous patients were also identified in Kinshasa. Other countries such as Burundi, along with several African countries, are also reporting significant numbers of cases,” the spokesperson added.

Study researchers noted that brincidofovir is approved for use in adult and pediatric patients, including infants. “This is important because we may be enrolling children with measles co-infection who may have just been vaccinated against measles. However, we do not plan to include patients who have recently received vaccination against Mpox,” the researchers explained.

“Africa is not just responding to the Mpox outbreak; We are leading the way in advancing research and development for Mpox therapeutics,” said Dr. Jean Kaseya, Director General of the Africa CDC. “The MpOx study in Africa is a groundbreaking step towards developing an effective treatment that will save lives. This goes beyond research – it is about African ownership and leadership in addressing our continent’s health challenges through fundamental research.”

“The launch of MOSA represents a significant step in the fight against Mpox and underlines Africa’s leadership in global health research and innovation,” said Prof. Samba Ousmane Sow, Director General of the Center for Vaccine Development in Mali (CVD-Mali) and President of the Board by PANTHER. “Our collaboration with Africa CDC will not only address an urgent health crisis, but also set a new standard for African-led research initiatives.” The study will include regular interim analyzes that may lead to a decision to terminate the study early due to lack of effectiveness or high likelihood of success . The first interim analysis is expected in early 2025.