Tekmira Pharmaceuticals, a developer of RNA interference (RNAi) therapeutics, has initiated patient enrolment in its Phase 1 clinical trial of TKM-Ebola.
TKM-Ebola is a systemically delivered RNAi therapeutic that leverages the company’s lipid nanoparticle (LNP) delivery technology, for the treatment of Ebola virus infection.
The Phase 1 placebo-controlled single-blind single-ascending dose (SAD) study, with additional multiple-ascending dose (MAD) cohorts, is conducted in 56 healthy adult subjects to evaluate the safety and tolerability of TKM-Ebola.
The study includes two stages – the SAD phase will have up to six cohorts with four subjects, three receiving TKM-Ebola and one receiving placebo in each cohort, while the MAD portion of the study will have up to three cohorts with four subjects per cohort, with three receiving TKM-Ebola and one receiving placebo in each cohort.
The trial will also demonstrate the pharmacokinetics and systemic exposure following both a SAD and MAD of TKM-Ebola.
Tekmira president and CEO Dr. Mark J. Murray said: "TKM-Ebola continues to be developed under a $140m contract with the US Government’s Transformational Medical Technologies (TMT) programme, which allows us to advance this programme to FDA approval as well as develop further innovations to Tekmira’s broader LNP technology platform."
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The TMT programme supports further development of Tekmira’s LNP technology, resulting in a 100-fold scale up of the LNP manufacturing process as well as the development of a lyophilisation process.
The LNP technology, formerly referred to as stable nucleic acid-lipid particles or SNALP, encapsulates siRNAs in uniform lipid nanoparticles that are effective in delivering RNAi therapeutics to disease sites.
The company is developing TKM-Ebola under specific FDA regulatory guidelines, which are intended to advance therapeutics that cannot meet the requirements for traditional approval.
Tekmira Pharmaceuticals is a biopharmaceutical company focused on developing novel RNAi therapeutics and providing its lipid nanoparticle delivery technology to pharmaceutical partners.