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February 10, 2014
08:31 EDTSRPTSarepta reports results from Phase 1 study of Marburg drug candidate
Sarepta Therapeutics announced positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers. AVI-7288, which uses Sarepta’s advanced and proprietary PMOplus chemistry, is the company’s lead drug candidate for the treatment of Marburg virus infection. Sarepta has been developing AVI-7288 under a Department of Defense contract managed by the Medical Countermeasure Systems BioDefense Therapeutics Joint Product Management Office. The Phase I clinical study was a randomized, double-blind, placebo-controlled trial that enrolled 40 healthy adult volunteers, and was designed to characterize the safety, tolerability and pharmacokinetics of AVI-7288 after daily repeat dosing. In each of five cohorts, six subjects received AVI-7288 and two subjects received placebo, daily for 14 days. Results showed that AVI-7288 was well tolerated through the highest dose tested, 16 mg/kg per day, which is higher than the anticipated therapeutic dose, with no reported serious or clinically significant adverse events. An independent Data and Safety Monitoring Board reviewed blinded safety results from the study and recommended continued clinical development of AVI-7288.
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