Tekmira Posts Ebola, Marburg Delay-To-Treatment Results

Tekmira Pharmaceuticals has posted positive preclinical data demonstrating the anti-viral efficacy of its TKM-Ebola and TKM-Marburg programs when treatment is delayed following infection.

TKM-Ebola, an anti-Ebola viral therapeutic, is being developed under a contract with the U.S. Department of Defense’s (DoD) Joint Project Manager Medical Countermeasure Systems (JPM-MCS), with a total contract value of approximately $140 million. Earlier preclinical studies were published in the medical journal The Lancet and demonstrated that when siRNA targeting the Ebola virus and delivered by Tekmira’s LNP technology were used to treat previously infected non-human primates, the result was 100% protection from an otherwise lethal dose of Zaire Ebola virus.

New preclinical data from the TKM-Ebola program has been generated showing survival in non-human primates despite infection with the most lethal Zaire variant of Ebola virus and delayed treatment. In a new study each cohort received seven daily treatments of 0.5 mg/kg TKM-Ebola beginning 24-, 48-, 72-, or 96-hours after infection. The study demonstrated 83% survival when treated 24- or 48-hours post infection and 67% survival when treatment was initiated at 72-hours, as compared to 0% survival rates in the placebo and 96-hour cohorts.

Tekmira anticipates the completion of preclinical and CMC studies and a submission to the FDA in 2H13 in order to support the use of a more potent product in a Phase I trial. The Phase I TKM-Ebola clinical trial is expected to be initiated in 1Q14 with data available in 2H14.

Marburg is also a member of the filovirus family of hemorrhagic fever viruses. Regularly occurring natural outbreaks of the Marburg Angola strain have resulted in mortality in approximately 90% of infected individuals, matching that of the most lethal Ebola strains. There are currently no approved therapeutics available for the treatment of Marburg infection. Data from a collaboration between Tekmira and the University of Texas Medical Branch (UTMB) showed 100% survival in non-human primates infected with the Angola strain of the Marburg virus. In earlier studies, 100% survival was achieved when dosing at 0.5 mg/kg TKM-Marburg began either one hour or 24 hours after infection with otherwise lethal quantities of the virus. Dosing then continued once daily for seven days.

In a new preclinical study, 100% survival was achieved when dosing at 0.5 mg/kg TKM-Marburg began 48 hours after infection with lethal quantities of the virus. Dosing was administered once daily for seven days. These studies represent the first known demonstration of protection of non-human primates from Marburg-Angola, the most lethal strain of Marburg virus.