By Mariam Sunny, Siddhi Mahatole and Jennifer Rigby
June 23 (Reuters) - The U.S. has provided doses of an experimental antibody drug from Mapp Biopharmaceutical for use in clinical trials to fight the widening Ebola outbreak in Democratic Republic of Congo, a Health Department spokesperson said.
The Department of Health and Human Services spokesperson declined to comment on the number of doses it will provide, saying by email that the drug is being made available for compassionate use in Congo as well
as to advance a clinical trial in the outbreak region.
The trial data could help inform future regulatory review and potential U.S. approval, the spokesperson said.
There are no approved vaccines or treatments for the Bundibugyo strain of Ebola, which has caused more than 1,000 cases in Congo, including more than 250 deaths. A handful of cases and deaths have also been reported in neighboring Uganda.
Doses of the Mapp drug and other therapeutics intended for trials are being shipped now, the World Health Organization told Reuters on Monday. The agency is working with health partners to prepare for trial enrolment in health facilities, the spokesperson said.
This marks the first time the U.S. government has indicated it plans to directly support clinical trials of the antibody treatment known as MBP134 from San Diego-based Mapp, by providing stockpiled doses. The U.S. had previously said doses would only be made available for Americans deemed to be at high risk after exposure to the virus.
The U.S. has pledged hundreds of millions of dollars to the Ebola response so far, and is building a controversial quarantine center in Kenya for American citizens, saying the priority is keeping Ebola from reaching the U.S.
TRIALS TO START IN COMING WEEKS
The Mapp drug is expected to be among the first to be tested in the outbreak, which was declared a public health emergency by the WHO just over a month ago and is already the third-largest Ebola outbreak on record.
Despite the urgency of the need, the WHO has said experimental treatments and vaccines should still be tested in clinical trials before widespread use.
Trials of the Mapp drug and two Gilead Sciences antivirals are due to begin in the coming weeks, according to the WHO and scientists involved in the testing.
Vaccines will take longer, the WHO has said, although a top official at an international vaccines group said earliest stage trials could begin next month, but probably not in Congo.
Running clinical trials in a conflict-hit part of the world, where disease testing and contact tracing are challenging, mistrust and attacks on health workers widespread, and supply chains disrupted, will be difficult, global health officials said.
Addressing these issues is a priority, the WHO said, as well as ensuring patients in the affected countries will be able to access the drugs after the trials if they are shown to be safe and effective.
TESTING MAPP AND GILEAD DRUGS
Mapp's MBP134 will be tested on its own as a treatment for Bundibugyo and alongside Gilead's antiviral remdesivir, also known as Veklury, which was widely used during the COVID-19 pandemic, the WHO said.
The Mapp drug trial is sponsored by the WHO and led by the University of Oxford alongside the Congolese and Ugandan governments.
Another Gilead antiviral, obeldesivir, will be tested as a potential preventive option, likely starting this month, the WHO and scientists involved said. This trial will be led by Congo, Uganda, the Africa Centres for Disease Control and Prevention, and co-sponsored by Congo's National Institute for Biomedical Research and France's ANRS Emerging Infectious Diseases agency.
Gilead declined to disclose details on shipments to Congo. Earlier this month, it said it was preparing to support requests for both drugs.
Ethics committees and regulators in Congo and Uganda are reviewing trial protocols, the WHO and Mapp said. The treatments have been shown in earlier trials to be safe but have not been tested for efficacy against Bundibugyo.
VACCINE TRIALS
Vaccine trials are a little further away, said WHO Director-General Tedros Adhanom Ghebreyesus in a press conference last week. Doses need to be manufactured and tested for safety and potential side-effects before being used in outbreak hot spots in the Congo.
Phase 1 trials could begin in July, likely in the UK and possibly Uganda, Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations, said in an interview.
CEPI has so far backed four vaccine candidates. The first to reach testing is likely one developed by Oxford and the Serum Institute of India, alongside another from U.S. vaccine maker Moderna based on mRNA technology.
"We have the resources, and how the trials will be stood up and implemented, and where the Phase 1s will be done," said Hatchett. "Anything beyond that is still being worked out."
(Reporting by Mariam Sunny and Siddhi Mahatole in Bengaluru and Jennifer Rigby in London; Editing by Caroline Humer and Bill Berkrot)
