WHO Prepares Clinical Trial of Experimental Ebola Treatments as Bundibugyo Outbreak Spreads Across Central Africa
核心洞察
The World Health Organization is preparing a clinical trial of two experimental treatments, remdesivir and MBP134, to combat the ongoing Bundibugyo Ebola virus (搜索) outbreak in the Democratic Republic of the Congo and Uganda.
The outbreak has resulted in 348 suspected cases and 89 deaths, with no currently approved treatments or vaccines available for this specific Ebola virus species.
MBP134, a monoclonal antibody treatment developed by Mapp Biopharmaceuticals (搜索), showed promising results in animal studies with five out of six infected monkeys recovering from Bundibugyo virus infection.
Scientists are racing to trial experimental treatments against the Bundibugyo species of Ebola virus as an outbreak spreads across the Democratic Republic of the Congo (DRC) and Uganda. The World Health Organization is preparing a clinical trial of two investigational therapies, pending approval by the governments of both affected countries.
The outbreak has been linked to 348 suspected cases including 89 deaths, according to data from the US Centers for Disease Control and Prevention as of May 18. There are currently no approved treatments or vaccines against the Bundibugyo species of the Ebola virus, making the rapid deployment of experimental therapies critical.
Experimental Treatments Under Investigation
The WHO-sponsored clinical trial will focus on two therapies: remdesivir, a broad-spectrum antiviral manufactured by Gilead Sciences, and MBP134, a mixture of two antibodies developed by Mapp Biopharmaceuticals (搜索) in San Diego, California.
"I think we're in a really strong position to quickly launch trials," says Amanda Rojek, a clinical researcher at the University of Oxford who is part of the WHO effort to rapidly trial treatments against filoviruses (搜索) during outbreaks. "We're working day and night at the moment."
Remdesivir was previously trialled in the DRC during a 2018-19 outbreak of the Zaire species of ebolavirus, as well as against SARS-CoV-2 during the COVID-19 pandemic, showing modest efficacy. MBP134 was administered during a 2022 outbreak of the Sudan species in Uganda, but this was done outside a clinical trial under 'compassionate use' protocols, making it impossible to determine the drug's effectiveness.
Promising Animal Study Results
Strong preclinical data supports the potential effectiveness of MBP134 against the Bundibugyo virus. In a 2019 study, researchers found that MBP134 led to profound recovery in five out of six monkeys that were infected with the Bundibugyo virus and showing symptoms such as fever.
"It's a true therapeutic — we've used it against Bundibugyo and it works fantastically, and you can wait until they're very sick," says Thomas Geisbert, a virologist at the University of Texas Medical Branch in Galveston who conducted the animal studies. "It really mimics someone that walks into a clinic and is very sick."
Larry Zeitlan, president of Mapp Biopharmaceuticals (搜索), confirmed that the company has sufficient doses of MBP134 for a trial, with the drugs owned by the US government's Biomedical Advanced Research and Development Authority (BARDA (搜索)).
Coordinated Government Response
U.S. officials are working with Mapp Biopharmaceutical to make the experimental Ebola treatment available for people who may have been exposed to the virus. The investigational monoclonal antibody treatment was developed through a longstanding public-private partnership supported by BARDA (搜索) to address Sudan virus, which is closely related to other ebolaviruses.
Laboratory data suggest the treatment has the potential to be effective against the Bundibugyo ebolavirus, the cause of the current outbreak. Any potential use of the product is being coordinated through a whole-of-government approach involving ASPR, FDA, and the Department of State.
Outbreak Severity and Global Concern
The Ebola outbreak in eastern Democratic Republic of the Congo that likely started two months ago has killed more than 130 people and is expected to continue to grow, according to the World Health Organization. Six hundred suspected cases and 139 suspected deaths have been recorded, with confirmed cases also reported in neighboring Uganda.
The WHO has classified the outbreak as a public health emergency of international concern. The outbreak has alarmed experts because it spread undetected for weeks in a densely populated area, and first responders have reported lacking basic supplies needed to help contain the spread.
There is currently no approved vaccine or virus-specific treatment for the Bundibugyo strain, and any potential vaccine could take months to develop, making the rapid deployment of experimental treatments a critical priority in the response effort.