What is TKM-Ebola?

TKM-Ebola is an experimental drug designed to prevent and defeat the Ebola virus. Formerly known as Ebola-SNALP, the drug was first put forward for a clinical trial by Tekmira Pharmaceutical Corp., a Canadian company, in January 2014. The company, based out of Vancouver, have a $140 million contract with the US Department of Defence to pursue research of the drug.

But first, what is Ebola?

Ebola is a deadly virus which attacks the human immune system by preventing its production of antibodies. As yet, no cure for the disease has been found, though several experimental drugs are in the pipeline, including TKM-Ebola.

The latest outbreak of the disease occurred late last year in Guinea, a country in western Africa. On the 6^th December, a two-year-old child died as a result of contracting the disease, and scientists have traced its outbreak back to this moment. Since then, the virus has claimed approximately 2,296 lives among a suspected 4,293 cases. Although, the World Health Organisation (WHO) unfortunately fears this figure may be significantly higher.

Experts estimate that if left untreated, around 60% of patients who contract the disease will die – some estimates even put that figure as high as 90%. With the disease spiralling out of control, new experimental drugs are being fast-tracked to try and combat it, despite not yet being approved by the FDA. TKM-Ebola is one of these possible candidates. This recent article, Fighting Ebola with Experimental Treatments, looks at this development in more detail.

The development of TKM-Ebola

In May 2010, Tekmira worked in tandem with the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and Boston University to demonstrate how their ribonucleic acid interference (RNAi) therapy produced startling results in monkeys infected with a lethal dose of Zaire Ebola virus. Of all the monkeys tested, 100% survived.

Off the back of this research, Tekmira was granted a $140 million contract with the US Department of Defense to continue their work. In 2013, this was expanded to include more lipid nanoparticle (LNP) technology, which was hoped to maximise the drug’s potential.

In January 2014, a clinical trial assessing the safety and the effectiveness of the drug in humans was commissioned. However, in July of the same year, the project was put on hold due to some test subjects reporting flu-like symptoms and assessments were called for to determine whether the symptoms were a bi-product of the drug or simply coincidental. Despite this, due to the escalating crisis in Africa, the status of TKM-Ebola was changed to “partial hold” the following month to allow its deployment in humans suffering from the virus.

Due to the current abnormal situation, development of the drug is being continued under a loophole of the FDA known as the “Animal Rule”. This states that a drug may be passed for commercial production without the necessity of human efficacy testing, if:

1. Undertaking such testing is not feasible or is not morally advisable
2. Comprehensive animal testing suggests that the drug may be beneficial when administered to humans
3. The drug meets all safety requirements regarding human administration.

Recently, we compared the death rates due to Ebola against other deadly infectious diseases. Despite the shocking headlines about Ebola, you may be surprised by the results in this infographic.