MIAMI, Aug. 12, 2019 /PRNewswire/ -- Ridgeback Biotherapeutics LP, a closely held biotechnology company provides an update on mAb114, an experimental treatment for Ebola.
Earlier today, the leaders of the Pamoja Tulinde Maisha (PALM [together save lives]) study announced that early termination of the four-arm study and changes in treatment for patients with Ebola. The PALM study is a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114 and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on November 20, 2018 in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces. As of August 9, 2019, the trial had enrolled 681 patients toward an enrollment goal of 725. Patients were enrolled at four Ebola Treatment Centers (ETCs) in Beni, Katwa, Butembo and Mangina. These ETCs 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). The study is co-sponsored and funded by the INRB and the National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health and carried out by an international research consortium coordinated by the World Health Organization (WHO).
The trial is monitored by an independent Data and Safety Monitoring Board (DSMB) that meets periodically to review interim safety and efficacy data. As a result of their August 9, 2019 review, the DSMB recommended that the study be stopped and that all future patients be randomized to receive either REGN-EB3 or mAb114 in what is being considered an extension phase of the study. This recommendation was based on the fact that an early stopping criterion in the protocol had been met. The preliminary results in 499 study participants indicated that those individuals receiving REGN-EB3 or mAb114 had a greater chance of survival compared to those participants in the other two arms.
"The PALM trial is an extraordinary example of how multiple countries, government agencies and pharmaceutical companies can work together to help patients in need. The leaders of the PALM trial have done an amazing job conducting a scientifically rigorous trial during an extremely complicated Ebola outbreak. Focused leadership combined with an incredibly dedicated team of selfless people have made the PALM trial a possibility. While pursuing rigorous research to determine the best treatments for patients; the primary goal of the PALM team members has always been clear – to help Ebola patients suffering from this aggressive disease that knows no boundaries. None of this could have happened without the support and trust of patients and their families and à vous, nous disons le plus grand merci (to you we say the biggest thank you)," said Wendy Holman, CEO and co-founder of Ridgeback Biotherapeutics LP.
Initially developed by the NIH, mAb114 was licensed by Ridgeback Biotherapeutics LP in the fourth quarter of 2018. Ridgeback Biotherapeutics is focused on completing the advanced development of mAb114, including supporting the work necessary for FDA licensure and ensure an adequate supply of mAb114 is available to support treatment during the current and future Ebola outbreaks.
"I am very proud of what the Ridgeback team has accomplished in less than a year and we will continue to concentrate on ensuring that mAb114 is available to respond to the current and any future outbreaks. Delivering promising treatments to patients in need is what makes us excited to come to work every day. We, like so many others in the infectious disease world, do what we do because we hope to make a difference. Today's news from the PALM trial helps to reinvigorate us and keeps us fixated on our mission."
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. To date, all funding for Ridgeback Biotherapeutics has 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