Aviceda Therapeutics has announced the commencement of part two of the Phase II/III SIGLEC trial of its ophthalmic candidate, AVD-104, for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The company has dosed the first subject in this part of the trial.
The double-masked, multicentre, randomised, controlled trial will compare AVD-104 with an active comparator, avacincaptad pegol, over 12 months, with an optional extension of an additional 12 months.
It will analyse the efficacy and safety of AVD-104 versus avacincaptad pegol to treat GA.
In the trial, subjects will receive either a low or high dose of AVD-104 or the active comparator.
The variation in the growth rate of the GA area at 12 months, as measured by fundus autofluorescence is the trial’s primary endpoint.
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Various other visual and anatomic efficacy measures will also be assessed in the trial.
Part 1 open-label safety and dose-escalation portion of the SIGLEC trial in 30 patients showed that all the subjects tolerated a single intravitreal injection of AVD-104 over three months.
Furthermore, no severe drug-associated ocular or systemic adverse reactions were seen in the participants.
Aviceda focuses on developing glyco-immune therapeutics. AVD-104 is developed using its HALOS nanotechnology platform.
The candidate aims to modulate inflammation by acting on specific immune cells and diseases.
Aviceda chief medical officer and senior vice-president David Callanan said: “Based on the efficacy and safety we saw in part one, we moved rapidly to initiate part two by activating sites and enrolment for this potentially disease-modifying treatment.
“In part one 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 three 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.”