The Phase II study of drug candidate TKM-Ebola-Guinea is the second to be financed by the UK Wellcome Trust’s £3.2m ($4.8m) Ebola fund. An earlier trial of the antiviral brincidofovir was abandoned this year following a sharp drop in Ebola cases at the study site in Liberia.
This second candidate, developed and manufactured by Tekmira Pharmaceuticals, is a synthetic small interfering RNA (siRNA) drug which targets the virus strain behind the current outbreak in Guinea, Liberia and Sierra Leone.
It works by blocking certain Ebola virus genes to reduce viral replication.
Tekmira previously tested a version of its drug targeted at a different form of the virus – the Kikwit strain – in healthy human volunteers.
The latest trial will evaluate efficacy of the Guinea version – “Ebola virus Makona” – in patients infected with Ebola. The new candidate is designed to match the genomic sequence exactly, with two RNAi triggers. The single-arm study is named RAPIDE-TKM (Phase II Rapid Assessment of Potential Interventions & Drugs for Ebola-TKM). Results are expected in late 2015.
It is led by Peter Horby, the University of Oxford’s Associate Professor of Infectious Diseases and Global Health, on behalf of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC).
He will work in partnership with the Sierra Leone College of Medicine and Allied Health Sciences, the Sierra Leone Ministry for Health, the WHO-based Special Programme for Research and Training in Tropical Diseases (TDR), the UK Department for International Development (DFID), Public Health England and GOAL Global.
Horby said it is important to begin clinical trials while new cases of Ebola are still being contracted so scientists can get answers about which treatments will save lives in future outbreaks. About 10 new Ebola patients are diagnosed daily in Sierra Leone.
Jeremy Farrar, Director of the Wellcome Trust, added the recent surge in new Ebola infections in Guinea and Sierra Leone are “a stark warning” that the epidemic is far from over.
“Almost a year on from the first confirmed case, we’ve reached a crucial stage where several large scale trials are gathering steam, but we still don’t have any proven treatments. It’s therefore heartening to see this latest trial of TKM-Ebola getting underway after so much hard work from the research team and partner agencies.”
The Wellcome Trust Ebola therapeutics platform was set up in September 2014 to help third parties quickly set up clinical trials at existing Ebola treatment centres.
Tekmira is based in Vancouver, Canada, and Seattle, USA, and usually focuses on using nucleic acid delivery to develop a therapy for the chronic hepatitis B virus.