AVI is conducting this work under a Department of Defense contract managed by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office.
Data from 60 subjects in 12 cohorts from the AVI-6002 and AVI-6003 studies combined were evaluated by an independent Data and Safety Monitoring Board (DSMB), which issued recommendations for both studies to progress as planned to multiple ascending dose studies after no safety concerns were identified. The Phase I single ascending dose trials were designed to characterize the safety, tolerability and pharmacokinetics of each therapeutic candidate in healthy adult volunteers.
"The favorable safety profiles of these two candidates show promise for drugs that utilize our PMOplus® chemistry," said Chris Garabedian, president and CEO of AVI BioPharma. "These data underscore how our chemistry may be safe independent of the sequence that is targeted, which we believe will support applications to other disease targets."
The Phase I multiple ascending dose studies are planned to characterize the safety, tolerability and pharmacokinetics of multiple doses of AVI-6002 and AVI-6003 in healthy adult volunteers. The randomized, double-blind placebo controlled studies will be overseen by a DSMB, who will review safety and clinical laboratory data after each dose cohort prior to enrolling the next highest dose cohort.
AVI-6002 and AVI-6003 are AVI's lead therapeutic candidates for the Ebola and Marburg viruses, respectively. Both candidates employ AVI's patented PMOplus® technology that selectively introduces positive charges to its phosphorodiamidate morpholino oligomer (PMO) backbone to improve interaction between the drug and its target.