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news.The US Food and Drug Administration (FDA) has notified Tekmira Pharmaceuticals that the partial clinical hold on its investigational new drug (IND) application for TKM-Ebola, an anti-Ebola virus RNAi therapeutic, has been modified to permit repeat dosing of healthy volunteers at a dose of 0.24 mg/kg/day.
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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.