Tekmira Pharmaceuticals Corporation has revealed that the Phase II clinical trial of its Ebola treatment TKM-Ebola-Guinea has reached a predefined statistical endpoint and that they have closed the enrollment indicating that the drug doesn’t demonstrate an overall therapeutic benefit. The company revealed that data analysis is still going on and full results will be made available as soon as possible.
The trail evaluated TKM-Ebola-Guinea for efficacy in Ebola virus infected patients in Sierra Leone, West Africa. TKM-Ebola-Guinea, is a synthetic small interfering RNA (siRNA) therapeutic developed and manufactured by Tekmira Pharmaceuticals. 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.
“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. 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,” 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, and has therefore completed, final conclusions on the efficacy and tolerability of the drug must await full analysis of the data.”
The University of Oxford, which is the representative of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) is responsible for conducting the Phase II study, with funding provided by the Wellcome Trust.