FDA Lessens Clinical Hold on Tekmira’s Ebola Treatment

Canadian biotech company Tekmira will restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, following the FDA’s downgrading of a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day.

Healthy volunteers will receive one dose daily at that level for seven days, Tekmira says.

A hold still applies to repeat doses of TKM-Ebola higher than that dose.

The FDA ordered a full clinical hold in July over concerns that the drug’s multiple ascending doses might provoke a deadly immune reaction called a cytokine storm. A month later, the agency scaled back to a partial hold that let the company give the drug to anyone with a suspected or confirmed Ebola infection.

Last month, Tekmira announced that TKM-Ebola-Guinea would be included in an open-label Phase II study in Sierra Leone being run by Oxford University and the Wellcome Trust. The Ebola-Guinea strain, known as “Ebola virus Makona,” is responsible for the outbreak in West Africa.

Results of both studies, expected in the latter half of this year, will help the company determine if the drug works well enough to continue with clinical development. — Lena Freund