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NIH ships doses of US government-developed Ebola drug to Congo

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NIH ships doses of US government-developed Ebola drug to Congo

The U.S. National Institutes of Health has shipped 10 treatment regimens of an experimental Ebola drug it developed to the Democratic Republic of the Congo and is prepared to send up to 100 regimens if needed in response to the current outbreak.

The drug, dubbed mAb114, is a monoclonal antibody — a protein that binds to a single target on a pathogen — and was developed by a research team at the U.S. National Institute of Allergy and Infectious Diseases, or NIAID, part of the NIH, under a partnership with the U.S. Army Medical Research Institute of Infectious Diseases and the American military's Defense Advanced Research Projects Agency.

NIAID Director Anthony Fauci last week disclosed that the Ministry of Health and Population of the Democratic Republic of the Congo had requested supplies of mAb114 for use in Ebola patients under a research protocol.

The drug is being tested in a phase 1 trial in the U.S., which got underway last week. The study, which is seeking to enroll up to 30 healthy, adult volunteers by July, is examining the safety and tolerability of mAb114.

The NIAID told S&P Global Market Intelligence it sent the 10 treatment regimens of mAb114 to the National Institute of Biomedical Research in Kinshasa, DRC, which was designated by the Ministry of Health and Population as the lead research coordination group for the current Ebola outbreak.

Details about the protocol for the DRC study of mAb114 have yet to be disclosed, but Peter Salama, deputy director-general of emergency preparedness and response at the World Health Organization, told reporters May 29 that health officials are hoping to test the NIH drug against four other experimental products to know for future outbreaks which medicine will provide the best efficacy. The medicines are Mapp Biopharmaceutical Inc.'s monoclonal antibody cocktail ZMapp; Gilead Sciences Inc.'s antiviral remdesivir, or GS-5734; Regeneron Pharmaceuticals Inc.'s fixed-dose monoclonal antibody combination treatment REGN3470-3471-3479; and FUJIFILM Holdings Corp.'s antiviral favipiravir, also known as Avigan.

No easy task

Salama noted that undertaking those comparative trials in the DRC will be no easy task, given the lack of electricity, functioning laboratories and stable infrastructure in the outbreak area as well as the complexity involved in testing monoclonal antibodies.

"This is no simple piece of work," he said. "But if we don't learn now, then we'll never know which are the best drugs to use in these situations."

The NIH's drug is being manufactured for the U.S. and DRC clinical trials by AstraZeneca PLC's U.S. unit MedImmune.

Salama reported that 54 people in the DRC have been infected with Ebola, with 35 of those cases confirmed through laboratory testing. He said 25 of those people have died of the highly contagious hemorrhagic fever virus.

During the 2014-15 Ebola outbreak in West Africa, more than 28,600 people were infected, with the virus killing over 11,300.