This trial is a multi-center, open-label safety and tolerability study enrolling 30 patients to evaluate a low and high dose of AVD-104 with 3-month follow-up.
Aviceda Therapeutics has enrolled the first patient in the GLYCO Phase 2 US clinical trial to evaluate AVD-104 for the management of diabetic macular edema (DME). As the company’s lead ophthalmic candidate, 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.1
In the press release1, Ashkan Abbey, MD, of Texas Retina Associates is noted as the provider who dosed the first patient, saying “I am honored to dose AVD-104 in the first patient in the GLYCO trial to evaluate its potentially next-generation dual mechanism of action to reduce the chronic inflammation that drives many cases of DME.”
Mohamed Genead, MD, Aviceda’s Co-founder and CEO shared that the company is looking forward to the results of this trial and the potential it can have on treating patients with DME, saying, “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.”1
David Callanan, MD, Aviceda’s Chief Medical Officer and Senior Vice President, is quoted in the news release1 as to the importance of continued treatment research and how it can benefit patients. He 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.”
The GLYCO Phase 2 US clinical trial is designed to evaluate the safety and treatment effects of intravitreal AVD-104 in patients with DME. This trial is a multi-center, open-label safety and tolerability study enrolling 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.1