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Trial Shows Two Drugs Can Treat Ebola Virus

Ebola virus

Ebola virus (Defense.gov)

13 Aug. 2019. A clinical trial in the Congo shows two different therapies made with synthetic antibodies are better able to treat Ebola infections than two other drugs tested. National Institute of Allergy and Infectious Diseases, or NIAID, also said yesterday results of the trial were conclusive enough to stop the full trial early and recommended extending the study with only the two more effective treatments: REGN-EB3 made by Regeneron Pharmaceuticals and mAb114 from Ridgeback Biotherapeutics.

The most recent Ebola outbreak is taking place in Democratic Republic of the Congo in central Africa that began in the summer of 2018. World Health Organization says as of 28 July, 2,577 cases of Ebola are confirmed in the country, causing 1,696 deaths. Adding in probable occurrences of Ebola, the numbers increase to 2,671 total cases and 1,790 deaths.

The mid- and late-stage clinical trial, known as the PALM study — short for Pamoja Tulinde Maisha, a Swahili phrase that roughly translates to Together Save Lives — is enrolling 1,050 participants, both children and adults, at four sites in the Congo diagnosed with early Ebola virus infections. Participants are randomly assigned to receive one of four Ebola therapies, one current drug and three experimental treatments:

ZMapp by Mapp Biopharmaceutical, already approved as an Ebola treatment and considered the standard of care

REGN-EB3 by Regeneron Pharmaceuticals

mAb114 by Ridgeback Biotherapeutics

Remdesivir by Gilead Sciences

The PALM trial began in November 2018, and as of 9 August enrolled 681 participants. The research team from NIAID, Congolese health authorities, and international medical humanitarian groups is looking primarily at relative mortality rates of participants after 28 days, as well as presence of Ebola virus in participant blood samples and serious adverse effects at various points up to 28 days.

Preliminary results with 499 participants show individuals with Ebola receiving REGN-EB3 and mAb114 have a greater chance of survival than those receiving ZMapp or remdesivir. The trial’s independent data and safety monitoring board recommended the full trial be stopped, but the study continue with participants randomly assigned to receive either REGN-EB3 or mAb114. The preliminary data, says the board, are compelling enough to recommend and implement this change in procedure.

“REGN-EB3 is a three-antibody cocktail designed with the goal of enhancing efficacy, reducing the development of viral sequences that lead to resistance, and increasing potential utility in future outbreaks as viruses continually evolve,” says Christos Kyratsous, vice president of research, infectious diseases and viral vector technologies at Regeneron in a company statement.

As reported by Science & Enterprise, Regeneron, in Tarrytown, New York, received a contract in September 2015 from Biomedical Advanced Research and Development Authority, or BARDA to develop a synthetic highly-target human antibody to treat Ebola. BARDA is an agency of the U.S. Department of Health and Human Services.

mAb114 is also a synthetic antibody, originally developed by NIAID — part of National Institutes of Health — and labs in the Democratic Republic of the Congo and Switzerland, as an Ebola treatment. The antibody is based on samples taken from survivors of a 1995 Ebola outbreak in the Congo, Ridgeback Biotherapeutics, a biotechnology company in Miami, Florida, licensed mAB114 from NIAID in December 2018 for further development.

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