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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData

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.”