MIAMI, Nov. 28, 2019 /PRNewswire/ -- Ridgeback Biotherapeutics LP, a closely held biotechnology company, today announced that the results for the Pamoja Tulinde Maisha (PALM ["Together Save Lives" in the Kiswahili language]) clinical trial have been published in the New England Journal of Medicine. The PALM study was organized by an international research consortium coordinated by the World Health Organization (WHO). It is led and funded by the DRC's National Institute for Biomedical Research (INRB) and Ministry of Health, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health.
The study was designed to compare mortality among patients who received one of three investigational Ebola drugs with that from a control group of patients who received the investigational monoclonal antibody cocktail ZMapp, developed by Mapp Biopharmaceutical, Inc. Mortality rates were lower for mAb114 treated patients: 35% (61/174) of patients in the mAb114 treatment group vs 50% (84/169) for the control arm (p=0.007). The Mortality rate for mAb114 treated patients with low viral load (CT>22) was 10%.
"This landmark study will permanently change the outlook for Ebola patients. Ebola is a disease that can be treated, especially if patients are treated early in the course of the disease. The PALM trial coordinators were able to accomplish a feat which many said could not be done – conduct a scientifically rigorous clinical trial in the midst of a complicated and ever-changing Ebola outbreak. The results published today demonstrate the incredibly robust impact that mAb114 has on this devastating and deadly disease. The heroes behind this discovery are the patients, their families and the extraordinary PALM study team – their contributions will forever change the trajectory of this brutal disease," said Wendy Holman, CEO of Ridgeback Biotherapeutics.
Ridgeback Biotherapeutics licensed mAb114 from NIAID's Vaccine Research Center. The company has applied for and has been granted Orphan Drug Designation and Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). Ridgeback Biotherapeutics is in the process of filing a Biologics License Application for mAb114 with the FDA and is manufacturing additional supply of mAb114 for potential use in either the current or future Ebola outbreaks.
Ridgeback Biotherapeutics has been awarded a $14 million contract by the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services to manufacture mAb114 and support activities required for licensure from the FDA.
About Pamoja Tulinde Maisha (PALM):
The PALM study is co-sponsored and funded by the INRB (Institut National de Recherche Biomédicale) and the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health and carried out by an international research consortium coordinated by the World Health Organization (WHO). The Ebola treatment centers in the PALM trial have been overseen by staff from the Institut National de Recherche Biomédicale (INRB); the DRC Ministry of Health; and three medical humanitarian organizations: the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Médicins Sans Frontières (MSF).
mAb114 is a monoclonal antibody — a protein that binds to a single target on a pathogen — isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, a city in the DRC. Nancy Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID's Vaccine Research Center (VRC), and her team, in collaboration with researchers from the National Institute of Biomedical Research (INRB) in the DRC and the Institute for Research in Biomedicine and Vir Biotechnology, Inc.'s subsidiary Humabs BioMed, both based in Bellinzona, Switzerland, discovered that the survivor retained antibodies against Ebola 11 years after infection. They isolated the antibodies and tested the most favorable ones in the laboratory and non-human primate studies, and selected mAb114 as the most promising. Professor Jean-Jacques Muyembe, director general of INRB and one of the scientists involved in the original detection of the Ebola virus in 1976, played a key role in discovering mAb114.
About Ridgeback Biotherapeutics LP:
Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a privately held, majority woman owned biotechnology company focused on orphan and infectious diseases. Initial funding for Ridgeback Biotherapeutics originated from Wayne and Wendy Holman; two individuals committed to investing in and supporting technologies that will make the world a better place. The team at Ridgeback is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions.
SOURCE Ridgeback Biotherapeutics LP