Aviceda Therapeutics Initiates Phase 2 Trial for AVD-104 in DME Treatment

Aviceda Therapeutics announced a significant milestone in the development of its lead ophthalmic candidate, AVD-104, with the enrollment of the first patient in the GLYCO phase 2 US clinical trial. The trial aims to evaluate the efficacy and safety of AVD-104 in the management of diabetic macular edema (DME), a common and serious complication of diabetes.

AVD-104 is an engineered glycan (sialic acid) nanoparticle designed to address inflammation associated with DME. By targeting the self-pattern recognition receptors on overly activated retinal neutrophils, macrophages, and microglia, AVD-104 aims to repolarize these cells to their resolution state, thereby reducing inflammation. The novel mechanism of action holds promise for patients with DME driven by inflammatory and VEGF-mediated mechanisms.

Dr. Ashkan Abbey of Texas Retina Associates marked a crucial step in the GLYCO trial by administering the first dose of AVD-104 to a patient. The trial will assess the safety and treatment effects of intravitreal AVD-104 in 30 patients with DME, employing a multicenter, open-label approach with a 3-month follow-up period. Both low and high doses of AVD-104 will be evaluated, with the primary endpoint focused on the incidence and severity of ocular and systemic adverse events.

Aviceda's co-founder and CEO, Dr. Mohamed Genead, expressed excitement about the potential of AVD-104: “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."

Dr. David Callanan, Aviceda’s Chief Medical Officer and Senior Vice President, highlighted the therapeutic advantages of AVD-104: "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 trial's secondary endpoint analyses will include standard evaluations of treatment efficacy, such as macular thickness and vision. Furthermore, exploratory variables will investigate the potential impact of AVD-104 on macular ischemia.

As advancements in ophthalmic therapies continue to evolve, Aviceda's pursuit of innovative solutions underscores the commitment to addressing the unmet needs of patients with diabetic macular edema, offering hope for improved outcomes and a brighter future for those affected by this sight-threatening condition.