Aviceda Enrolls First Patient in Phase 2 GLYCO Clinical Trial Evaluating AVD-104 for the Treatment of DME

Aviceda Therapeutics announced that it has enrolled the first patient in the GLYCO phase 2 US clinical trial evaluating its lead ophthalmic candidate AVD-104 for the management of diabetic macular edema (DME). AVD-104 is an engineered glycan (sialic acid) nanoparticle that reduces inflammation by targeting the self-pattern recognition receptors on overly activated retinal neutrophils, macrophages, and microglia, and repolarizing them to their resolution state, according to Aviceda.

Ashkan Abbey, MD, of Texas Retina Associates, dosed the first patient in the GLYCO trial. 

“We are excited to evaluate the ability of AVD-104’s unique mechanism of action to provide DME patients with a safe treatment that may improve outcomes in eyes with DME driven by inflammatory and VEGF-mediated mechanisms," Mohamed Genead, MD, Aviceda’s co-founder and CEO, said in a company news release.

“AVD-104 down-regulates neutrophils and has been shown to reduce the release of inflammatory cytokines,” said David Callanan, MD, Aviceda’s Chief Medical Officer and Senior Vice President. “There is still a need for improvement in the treatment of DME and we believe it may offer therapeutic advantages in the management of DME, and potentially in diabetic ischemia.”

The GLYCO phase 2 trial will evaluate the safety and treatment effects of intravitreal AVD-104 in patients with DME. This multicenter, open-label safety and tolerability study will enroll 30 patients to evaluate a low and high dose of AVD-104 with 3-month follow-up. The primary endpoint will be the incidence and severity of ocular and systemic adverse events. Secondary endpoint analyses will include standard evaluations of treatment efficacy, including macular thickness and vision. Further exploratory variables will include the potential effect of AVD-104 on macular ischemia.

For more information on the GLYCO trial, click here.