In this preliminary efficacy trial there appears to be no difference in overall mean visual analog scale (VAS) scores between active and placebo arms, a pharmacokinetic assessment indicates an encouraging correlation between AV411 plasma levels and the number of patients that reported a decrease in pain scores as assessed by VAS. Additionally, there was a trend towards decreased opioid use that correlated with increased AV411 dose.
Paul Rolan, professor of pharmacology, University of Adelaide, Australia said: “The evidence of AV411’s favorable tolerability and potential dose response in this trial indicates AV411 is a promising non-opioid clinical candidate for chronic neuropathic pain. Larger and longer duration studies will be required to demonstrate efficacy over placebo.”
Kenneth Chahine, Avigen’s president and CEO, said: “We are pleased with the top line results which met the safety and tolerability objectives of the trial, as well as showed encouraging signs of efficacy in patients with neuropathic pain. This data now provides a valuable roadmap for the planning of our Phase II clinical program for AV411, a non-opioid therapy that can potentially reverse neuropathic pain without dose or therapy limiting side effects.”