The Endofer of the Ebola outbreak! 2 antibody therapies significantly reduce Ebola infection mortality

mAb114 is a monoclonal antibody that originated in the 1995 Ebola outbreak in Kikwete, Democratic Republic of the CongoIn that outbreak, survivors remained anti-Ebola antibodies for up to 11 years after contracting Ebola, and researchers isolated antibodies from those survivors, of which mAb114 was the most promisingIn the United States, in May and September this year, the FDA granted mAb114 Orphan Drug Qualification (ODD) and Breakthrough Drug Qualification (BTD), respectivelyPamoja Tulinde Maisha (PALM, Save Lives Together) is an international research consortium co-sponsored and funded by the National Institute of Biomedical Research (INRB) in Kinshasa, Democratic Republic of the Congo, and the National Institute of Allergy and Infectious Diseases (NIAID) of the United States National Institute of Health (NIH)The Ebola treatment centre in the study is supervised by staff of the National Institute of Biomedical Research (INRB) in Kinshasa, Democratic Republic of the Congo, the Ministry of Health of the Democratic Republic of the Congo and three medical humanitarian organizations: the International Union for Medical Action (ALIMA), the International Medical Team (IMC) and Doctors Without Borders (MSF)From 20 November 2018 to 9 August 2019, the PALM study enrolled a total of 681 patientsIn the study, these patients were treated with a ratio of 1:1:1 to 4 treatments, including three antibody therapies (antibody cocktail ZMapp, three monoantigen mixtures, REGN-EB3 (Regenerative Element, monoclonal antibody mAb114) and an antiviral drug remdesivir (Gilead), of which ZMapp was used as a controlThe main endpoint of the study was the treatment of 28-day mortalityresults showed that subjects treated with REGN-EB3 and mAb114 had a greater chance of survival than the other two groupsThe specific data for 28 days of treatment were: (1) ZMapp, remdesvir, mAb114, REGN-EB3, and the mortality rate of infection in each treatment group was 49.7% (84/169), 53.1% (93/175), 35.1% (61/174), 33.5 (52/155) ;(2) in patients treated early after infection and with low blood virus levels, the data were stronger, with mortality rates being 24.5% (24/98), 29.0% (29/100), 9.9% (10/101), 11.2% (10/89)Currently, the overall Ebola outbreak has a mortality rate of 67 per centBased on the above data, the PALM study was terminated prematurely and REGN-EB3 and mAb114 were selected as drugs for randomized treatment in all future patients during the extended period to further evaluate the safety of the assessment until the final clinical trial results are obtainedRidgetheback Bios obtained mAb114 license from the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research CenterThe company has applied for and obtained the U.SFood and Drug Administration (FDA) Issued Orphan Drug Qualification (ODD) and Breakthrough Drug Qualification (BTD)Ridgeback Biotherapeutics is submitting an mAb114 BiologicS License Application (BLA) to the FDA and is manufacturing an additional mAb114 supply for use in current or future Ebola outbreaksRidgeback Biodrugs has been awarded a $14 million contract from the U.SAdvanced Research and Development Agency for Biomedical Research (BARDA) to manufacture mAb114 and support the activities required by the FDA to licenseWendy Holman, chief executive of Ridgepath Bios,, said: "This landmark study will permanently change the outlook for Ebola patientsThe Ebola virus is a treatable disease, especially if the patient is treated early in the onset of the diseaseTHE PALM TEST COORDINATOR WAS ABLE TO ACCOMPLISH A FEAT THAT MANY COULD NOT ACHIEVE -- A SCIENTIFICALLY RIGOROUS CLINICAL TRIAL IN THE COMPLEX AND VARIED PROCESS OF THE EBOLA OUTBREAKThe results released today show the powerful effects of mAb114 on this devastating and deadly diseaseThe heroes behind this discovery are patients, their families and the extraordinary PALM research team whose contributions will forever change the course of this brutal diseaseoriginal origin of:1, Ridgeback Biotherapeutics LP announces of publications of mAb114 results in the New England Journal of Medicine2, A Random, Controlled Trial of Ebola Virus Disease