Vancouver, BC & Doylestown, PA – Tekmira Pharmaceuticals Corporation announced today its Phase II clinical trial of TKM-Ebola-Guinea has reached a predefined statistical endpoint and enrollment has been closed. In a statement, it said the endpoint indicated that continuing enrollment was not likely to demonstrate an overall therapeutic benefit. It added that data analysis is ongoing and the full results will be made available as soon as possible.
“It is a great tribute to the team 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 Dr. Peter Horby, associate professor of infectious diseases and global health, University of Oxford, Chief Investigator on the study. “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.”
In the trial, TKM-Ebola-Guinea was being evaluated for efficacy in Ebola virus-infected patients in Sierra Leone, West Africa. The Phase II single arm trial called RAPIDE (Rapid Assessment of Potential Interventions & Drugs for Ebola) is open-label with a concurrent observational study of Ebola virus disease in Sierra Leone.
The University of Oxford, which is the representative of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) was responsible for conducting the Phase II study, with funding provided by the Wellcome Trust.
The Ebola-Guinea strain is known as “Ebola virus Makona” the virus responsible for the current outbreak in West Africa. This strain diverges slightly from the Kikwit strain, which was the original target of TKM-Ebola. The genomic sequence of the Ebola-Guinea strain was determined from several viral isolates and published in the New England Journal of Medicine in October 20141. Tekmira developed a modified RNAi therapeutic, based on the Company’s original TKM-Ebola investigational therapeutic, to specifically target Ebola-Guinea. The new product, termed TKM-Ebola-Guinea, is designed to match the genomic sequence exactly, with two RNAi triggers.