AVI BioPharma, Inc. a developer of RNA-based therapeutics, announced that it initiated dosing of volunteers in a phase I clinical study of AVI-7100, the company's lead drug candidate for the treatment of influenza. AVI-7100 is a therapeutic candidate with a novel mechanism of action and potentially broad-spectrum activity against influenza viruses, including Tamiflu-resistant virus strains. This clinical trial is the third phase I programme initiated this year for an AVI infectious disease drug candidate.
In the randomized, double-blind, placebo-controlled study, AVI will assess the safety, tolerability and pharmacokinetics of AVI-7100 administered via intravenous infusion in single-ascending doses in up to 48 healthy adult volunteers. The study will have six cohorts consisting of six volunteers who receive the therapeutic and two who will receive a placebo.
“AVI-7100 offers a promising, novel approach with potential broad-spectrum activity for the treatment of influenza,” said Chris Garabedian, AVI's president and CEO. “This is especially important because of the decrease in utility of current flu therapies in light of the increase of drug-resistant strains of the virus. To support the continued development of the AVI-7100 influenza program and our mission of advancing innovative treatment options, we will respond to an RFP announced in May by the US Department of Defence seeking the full clinical development of influenza therapeutics for both prophylaxis and treatment.”
AVI-7100 is AVI's lead therapeutic candidate for the treatment of influenza. AVI-7100 targets 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 the more recently emergent Swine Origin Influenza Virus (SOIV), H1N1, are both caused by the influenza A virus. AVI-7100 employs the company's patented PMOplus technology that selectively introduces positive charges to a Phosphorodiamidate Morpholino Oligomer (PMO) backbone to improve selective interaction between the drug and its target. AVI-7100 was preclinically developed and identified as the lead candidate with support from the US Department of Defence's Joint Project Manager Transformational Medical Technologies (JPM-TMT) under contract HDTRA1-09-C-0046.
Preclinical studies funded under JPM-TMT contract HDTRA1-10-C-0079 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.
AVI BioPharma is focused on the discovery and development of novel RNA-based therapeutics for rare and infectious diseases, as well as other select disease targets.