Tekmira Pharmaceuticals Corporation, an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), announced today that TKM-Ebola-Guinea will be evaluated for efficacy in Ebola virus infected patients in Sierra Leone, West Africa. Patient recruitment has been initiated.
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. Study results are expected in the second half of 2015.
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 provide by the Wellcome Trust.
“We have been working judiciously these last few months to finalize a suitable clinical trial protocol and to receive all the necessary ethics and regulatory approvals to enable TKM-Ebola-Guinea to be clinically evaluated in patients in Sierra Leone,” said Dr. Mark J. Murray, Tekmira’s President and CEO. “This study will enable us to gather important clinical data that may help us to determine whether TKM-Ebola-Guinea is a promising treatment for patients infected with Ebola virus disease. We expect the results of the study to help inform us on the potential further development of this important therapeutic.”
Dr. Murray added, “New cases of Ebola virus disease infections are still occurring, and many people remain infected, which reinforces the critical need for effective therapeutics against this deadly disease. If we are eventually successful in obtaining market approval of TKM-Ebola-Guinea, the company would provide patients a therapeutic option for this terrible disease and in addition this may place the company on a path to receive a Tropical Disease Priority Review Voucher from the US FDA that we can apply to another product in development to support expedited approval.”
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 2014.
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. The ability to rapidly and accurately match the evolving genetic sequences of emerging infectious agents is one of the powerful features of RNAi therapeutics.