Pharmaceutical Business review

US FDA modifies partial clinical hold on Tekmira’s TKM-Ebola IND application

The company said that IND remains on partial clinical hold with regard to doses above 0.24 mg/kg/day in healthy volunteers.

The randomized, single-blind, placebo-controlled TKM-Ebola Phase I clinical trial will be resumed by the company in the coming weeks.

The trial involves repeat dosing of a single cohort of healthy volunteers and each subject will receive daily doses of 0.24mg/kg of TKM-Ebola or placebo for up to seven days.

Results from the TKM-Ebola Phase I trial are expected to be reported in the second half of 2015.

TKM-Ebola is being developed under a $140m contract with the US Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics (JPM-MCS-BDTX) Joint Product Management Office.

Earlier preclinical trials showed 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.