Ebola drugs emerge successfulOctober 8, 2019
Two drugs have emerged potential future treatments against Ebola virus demonstrating a cure rate of up to 90% in an ongoing clinical trial in the Democratic Republic of the Congo (DRC).
The first-ever multi-drug randomized control trial, initiated by the WHO evaluated the safety and efficacy of four investigational agents – ZMapp, remdesivir, mAb114 and REGN-EB3 — for the treatment of patients with Ebola virus disease.
An interim analysis of the trial data found that REGN-EB3 and mAB114 outperformed the others by improving the survival rate of the patients by 90% if administered shortly after the infection.
REGN-EB3 is a combination of three monoclonal antibodies made by Regeneron Pharmaceuticals and mAB114, a monoclonal derived from a single antibody recovered from the blood of a person who survived Ebola in the DRC in 1995 developed by the US National Institute of Allergy and Infectious Diseases (NIAID).
Data from the first 499 people enrolled in the study showed that 29% of people given REGN-EB3 died, compared with 34% of those who received mAb114.
In the meantime, 53% of patients who received the anti-viral drug remdesivir died. So was the case with ZMapp, where 49% of patients who received ZMapp died. ZMapp, an antibody treatment, was tested during a major Ebola outbreak in West Africa from 2014 to 2016.
As of August 9, 2019, the trial had enrolled 681 patients toward an enrollment total of 725.
After reviewing the interim data. an independent Data and Safety Monitoring Board (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.
The final analysis of the data is expected to be generated by late September/early October 2019. However, the DSMB felt the preliminary analysis of the existing data was compelling enough to recommend and implement these changes in the trial immediately.
The study Pamoja Tulinde Maisha (PALM [together save lives]) began on November 20, 2018 in DRC as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces.
Moving forward, these are the only drugs that future patients will be treated with. the WHO, Institut National de Recherche Biomédicale (INRB) and NIAID said in a joint statement.
The complete results will be submitted for publication in the peer-reviewed medical literature.