Enrollment complete in phase 2b study of AVD-104 for geographic atrophy secondary to AMD
Click Here to Manage Email Alerts
Aviceda Therapeutics has completed enrollment of its phase 2b SIGLEC study, which will compare the safety and efficacy of AVD-104 vs. Izervay in patients with geographic atrophy secondary to age-related macular degeneration.
“The current [geographic atrophy (GA)] landscape contains a number of unmet needs,” David Callanan, MD, Aviceda’s chief medical officer, said in a company press release. “Based on our differentiated dual mechanisms of action and strong phase 2a results, we believe AVD-104 has the potential to meaningfully alter the course of GA progression by enabling tangible functional benefits and neuroprotection of retinal tissue.”
According to the release, in phase 2a of the two-part SIGLEC trial, the researchers reported no drug-related ocular or systemic adverse effects at 3 months after a single intravitreal injection. Compared with untreated eyes, AVD-104 demonstrated a greater reduction in GA lesion progression, improved hyperautofluorescence imaging in the junctional zone and stabilization of best corrected visual acuity.
The multicenter, double-masked phase 2b study, also conducted in the U.S., will compare AVD-104 with Izervay (avacincaptad pegol, Astellas Pharma) in roughly 300 participants with GA secondary to AMD. Participants will be randomly assigned to high-dose AVD-104 every other month, low-dose AVD-104 monthly or avacincaptad pegol monthly for 12 months, with the primary endpoint being the difference in growth rate of the GA area between treatments. Study participants may continue for an additional 12 months, the company said.
According to the release, data from the phase 2b study are expected in 2025.
Click Here to Manage Email Alerts