The Wellcome Trust today provided an update on the status of the TKM-Ebola-Guinea drug clinical trial in Sierra Leone.
The study is no longer recruiting patients after reaching a pre-defined endpoint. Early results indicated that continued enrollment to the study, which has been running since March 2015, was unlikely to demonstrate an overall therapeutic benefit to patients.
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 centers.
The TKM-Ebola-Guinea research team is currently analyzing 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.
“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,” said Professor Peter Horby, Associate Professor of Infectious Diseases and Global Health at the University of Oxford and Chief Investigator of the study. “While the trial has reached a statistical endpoint, and has therefore completed, final conclusions on the efficacy and tolerability of the drug must await full analysis of the data.”