The development was based on a contract basis signed with US Department of Defense (DoD), which is managed by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office.
Sarepta Therapeutics president and CEO Chris Garabedian said the FDA recognizes the unmet medical need for the lethal hemorrhagic fever viruses and the necessity to move the development of the drugs forward as fast as possible to ensure effective medical countermeasures for the Warfighter.
"We believe Sarepta has the only drug candidates for Marburg and Ebola with Fast Track designation and expect this designation will provide an expedited approval process to help DoD achieve its mission of protecting the nation from biothreats," Garabedian added.
Following FDA’s Animal Rule, the company is evaluating the safety and efficacy of AVI-7288 for the treatment of Marburg virus and is also planning to start a Phase I multiple ascending dose study to demonstrate the safety, tolerability and pharmacokinetics of AVI-7288 after repeat dosing in healthy adult volunteers.
The company reports that development of AVI-7537, under the JPM-TMT’s Ebola program, is under a temporary stop-work order due to funding constraints.