Date: 2014-09-30
Type of information: Results
phase: 1
Announcement: results
Company: Sarepta Therapeutics (USA - MA)
Product: AVI-7100
Action
mechanism: AVI-7100 utilizes a novel mechanism of action to target a well-conserved region of the influenza A virus, affording it the potential to act as a broad-spectrum treatment for multiple influenza strains, including Tamiflu-resistant flu strains. Seasonal influenza (H3N2) and 2009 H1N1 are both caused by the influenza A virus. Preclinical studies funded by the U.S. Department of Defense demonstrated that AVI-7100 improved clinical symptoms and reduced viral titers in animal models infected with pandemic H1N1 or H3N2 viruses, and had statistically significant activity as compared to saline and Tamiflu® controls.
Disease: influenza
Therapeutic area: Infectious diseases
Country: USA
Trial
details: The Phase I clinical study is a randomized, double-blind, placebo-controlled trial designed to characterize the safety, tolerability and pharmacokinetics of single and multiple doses of an intravenous formulation of AVI-7100 in healthy adult volunteers. (NCT01747148)
Latest
news: * On September 30, 2014, Sarepta Therapeutics, a developer of innovative RNA-based therapeutics, announced safety results from the single ascending dose portion of a Phase I study of AVI-7100, the company’s lead candidate for the treatment of influenza virus, in healthy volunteers. The clinical trial is being conducted at the National Institutes of Health (NIH) through a collaboration between the company and the NIH’s National Institute of Allergy and Infectious Diseases. AVI-7100 uses Sarepta’s advanced and proprietary PMOplus™ chemistry, which is also the basis of the company’s clinical-stage Ebola and Marburg drug candidates.
The Phase I clinical study is a randomized, double-blind, placebo-controlled trial designed to characterize the safety, tolerability and pharmacokinetics of single and multiple doses of an intravenous formulation of AVI-7100 in healthy adult volunteers. In the completed single ascending dose portion, 40 subjects were enrolled in five cohorts (6 active: 2 placebo) up to the highest dose tested of 8 mg/kg AVI-7100. Results showed that AVI-7100 was well-tolerated with no reported serious or clinically significant adverse events. The pharmacokinetic analysis of AVI-7100 reveals a highly similar dose-dependent profile to that of Sarepta’s Ebola and Marburg PMOplus™ drug candidates. An independent Data and Safety Monitoring Board reviewed safety results from the study and recommended the study continue as planned to the multiple dose portion of the study.
