Aviceda reports positive topline data for AVD-104 in patients with geographic atrophy

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Key takeaways:

Reduction in GA lesion progression at 3 months was greater than historical standard-of-care outcomes.
No drug-related ocular or systemic adverse events were reported.

Aviceda Therapeutics announced positive safety and efficacy outcomes from part 1 of its phase 2/3 SIGLEC trial for AVD-104, which is being evaluated in patients with geographic atrophy secondary to age-related macular degeneration.

“We are excited to see signs of significant visual and functional improvement and rapid reduction in the rate of GA lesion growth with a positive overall safety profile following a single dose of AVD-104,” David Callanan, MD, chief medical officer and senior vice president at Aviceda, said in a company press release.

eyes — No drug-related ocular or systemic adverse events were reported and GA lesion progression was reduced at 3 months after a single dose of AVD-104. *Image: Adobe Stock*

The two-part trial is investigating the safety, pharmacokinetics and efficacy of intravitreal AVD-104, a glycan-coated nanoparticle designed to modulate inflammatory cellular and complement pathways, which also is being studied in patients with diabetic macular edema.

According to the release, results of the open-label portion of trial demonstrated that all 30 participants tolerated a single dose of AVD-104 at 3 months, with no drug-related ocular or systemic adverse events reported. In addition, a greater reduction in geographic atrophy (GA) lesion progression was observed at 3 months compared with historical standard-of-care outcomes, as well as significant best corrected visual acuity gains.

The second part, a double-masked, randomized, controlled trial, will examine safety and efficacy of AVD-104 compared with an active comparator in 300 participants dosed over 12 months, with an opportunity to continue for an additional 12 months.

“We look forward to initiating part 2 of SIGLEC, in which we hope to demonstrate the capability of AVD-104 to provide a meaningful improvement over therapy that is only based in complement inhibition,” Callanan said in the release.

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Aviceda reports positive topline data for AVD-104 in patients with geographic atrophy

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