First patient dosed in second part of trial for AVD-104 to treat geographic atrophy
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Aviceda Therapeutics announced the dosing of the first patient in the second part of its phase 2/3 SIGLEC trial investigating AVD-104 to treat geographic atrophy secondary to age-related macular degeneration.
“Based on the efficacy and safety we saw in part 1, we moved rapidly to initiate part 2 by activating sites and enrollment for this potentially disease-modifying treatment,” David Callanan, MD, Aviceda’s chief medical officer and senior vice president, said in a company press release.
The first part of SIGLEC was a multicenter, open-label safety and dose-escalation trial, in which 30 patients received an intravitreal injection of AVD-104. All patients tolerated a single dose at month 3, and no drug-related severe adverse events occurred, the release stated.
According to Aviceda, the second part of the trial is multicenter, double-masked and randomized to examine the safety and efficacy of AVD-104 compared with avacincaptad pegol. Patients will be dosed for 12 months, with an option to remain in the study for an additional 12 months. The primary outcome of interest is the difference in growth rate of the geographic atrophy area between AVD-104 and the comparator.
“If this dual-mechanism approach continues to prove to be safe and effective, we may soon see a paradigm shift in how we treat [geographic atrophy],” Mohamed Genead, MD, the company’s co-founder and CEO, said in the release.
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