Aviceda Announces First Patient Dosed in Part 2 of the Phase 2/3 SIGLEC Trial Assessing AVD-104 for GA

Aviceda Therapeutics announced it has dosed the first patient in part 2 of the phase 2/3 SIGLEC trial for AVD-104 in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

“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 news release. “In part 1 of SIGLEC, we found that AVD-104 had a positive safety profile, and that patients with GA dosed with AVD-104 showed BCVA improvements at 3 months. We will now further explore outcomes of AVD-104 on GA, this time with the opportunity to compare them to those of a comparator arm.”

Part 2 of the SIGLEC trial is a multicenter, double-masked, randomized, controlled trial that will assess safety and efficacy outcomes of AVD-104 and an active comparator (avacincaptad pegol) for the treatment of GA secondary to AMD. Patients will be dosed for 12 months, with the opportunity to remain in the study for an additional 12 months. Those assigned to treatment with AVD-104 will receive either low-dose AVD-104, high-dose AVD-104, or the active comparator. The primary endpoint will be the difference in growth rate of the GA area in patients treated with AVD-104 versus those receiving active comparator at 12 months as measured by fundus autofluorescence. Numerous other visual functional and anatomic efficacy measures will also be explored and compared between AVD-104 and the active comparator.

“Current treatment options for GA address only complement dysregulation,” said Aviceda Co-founder and CEO Mohamed Genead, MD. “AVD-104 addresses both macrophage/microglial-mediated inflammation while also targeting the complement pathway. If this dual-mechanism approach continues to prove to be safe and effective, we may soon see a paradigm shift in how we treat GA.”

Further information regarding the phase 2/3 SIGLEC trial can be found here.

Part 1 of the SIGLEC trial was a multicenter, open-label safety and dose-escalation trial of 30 patients who received a single intravitreal injection of AVD-104 and were followed for 3 months. In Part 1, all patients tolerated a single dose of AVD-104 at month 3, and no drug-related ocular or systemic severe adverse reactions were observed.