Early results indicated that continued enrolment to the study, which has been running since March 2015 in Sierra Leone, was unlikely to demonstrate an overall therapeutic benefit to patients.
The research team is currently analysing the data collected during the trial and will make the results available as soon as possible. The single-arm phase II study (RAPIDE-TKM), is led by Professor Peter Horby of the University of Oxford on behalf of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) in collaboration with the College of Medicine and Allied Health Sciences in Sierra Leone. The study is funded by the Wellcome Trust.
Professor Horby, Associate Professor of Infectious Diseases and Global Health at the University of Oxford and Chief Investigator of the study, said: ‘It is a great tribute to our colleagues in Sierra Leone that the trial has been run so efficiently and that we now have substantial experience on the use of TKM-Ebola-Guinea in patients with Ebola.
‘While the trial has reached a statistical endpoint, final conclusions on the efficacy and tolerability of the drug must await full analysis of the data. The endpoint was pre-specified to ensure we ran the study safely, objectively, and got an answer as quickly as possible. The trial has accomplished this.’
TKM-Ebola-Guinea, is a synthetic small interfering RNA (siRNA) therapeutic developed and manufactured by Tekmira Pharmaceuticals. It is one of a number of candidate Ebola treatments to be evaluated through the Wellcome Trust Ebola therapeutics platform, which was set up in September 2014 to enable multiple partners to quickly establish clinical trials at existing Ebola treatment centres.