The trial will evaluate AVD-104 for diabetic macular oedema treatment. Credit: memorisz/shutterstock.com.

Aviceda Therapeutics has dosed the first patient in the GLYCO Phase II clinical trial in the US, aimed at evaluating AVD-104 for diabetic macular oedema (DMO; DME in the US) treatment.

AVD-104 is an engineered glycan (sialic acid) nanoparticle designed to reduce inflammation. This is done by targeting the self-pattern recognition receptors on retinal neutrophils, microglia, and macrophages that are overly activated and repolarising them to their resolution state.

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The GLYCO Phase II trial will assess AVD-104’s safety and treatment effects when administered intravitreally in patients with DMO.

As part of the multi-centre, open-label safety and tolerability trial, 30 patients are planned to be enrolled to test both low and high doses of the therapy, with a three-month follow-up period.

The trial’s primary endpoint is to determine the incidences and severity of ocular and systemic adverse events.

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Secondary endpoints will focus on standard treatment efficacy evaluations, including macular thickness and vision.

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Aviceda co-founder and CEO Mohamed Genead said: “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.”

The company anticipates topline results from the GLYCO Phase II trial in the second quarter of 2024.

Aviceda chief medical officer and senior vice-president David Callanan said: “AVD-104 down-regulates neutrophils and has been shown to reduce the release of inflammatory cytokines.

“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.”

Aviceda also has a pipeline of products that are under development in ophthalmology and several other therapeutic areas, including immunology, oncology, neurology, and fibrosis.