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news.Sarepta Therapeutics has signed a Clinical Trial Agreement (CTA) with the US National Institute of Allergy and Infectious Diseases (NIAID) to conduct a phase I study with AVI-7100, its drug candidate to treat influenza viruses, including Tamiflu-resistant virus strains.
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Sarepta Therapeutics president and CEO Chris Garabedian said the agreement will lead to development of new treatment options for influenza with new mechanisms of action with limitations of presently available influenza antivirals.
”Our combined effort with the NIH will further increase our understanding of AVI-7100 and its underlying platform chemistry, which we are also applying to other infectious disease targets," Garabedian added.
The agreement allows NIAID researchers to carry on a phase I, double-blind, placebo-controlled, dose-escalating study to eveluate the safety, tolerability and pharmacokinetics of single and multiple doses of an intravenous formulation of AVI-7100 in healthy volunteers.
As part of the CTA, Sarepta will provide AVI-7100 to NIAID and have usage rights for the data received from the clinical study to support future development of the drug.